Skip to content
← Back to this collection

LABELS · ead30b86-564f-7e78-e053-2a95a90ab41c

Depo-Medrol

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2022-10-12
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Full extracted label fields
application numbers
  1. NDA011757
boxed warning exact
    brand names
    1. Depo-Medrol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
    generic names
    1. METHYLPREDNISOLONE ACETATE
    id
    ead30b86-564f-7e78-e053-2a95a90ab41c
    indications and usage exact
    1. INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
    indications and usage tables exact
      is original packager
        manufacturer names
        1. Asclemed USA, Inc.
        matched search terms
        1. cancer
        2. lymphomas
        3. tumor
        4. tumors
        package ndcs
        1. 76420-081-01
        product ndcs
        1. 76420-081
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. INTRA-ARTICULAR
          2. INTRALESIONAL
          3. INTRAMUSCULAR
          4. SOFT TISSUE
          rxcuis
          1. 1743855
          2. 1743856
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00700.json
          meta
          disclaimer
          Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
          last updated
          2026-09-09
          results
          limit
          100
          skip
          700
          total
          830
          sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          url
          https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
          spl effective date
          2022-10-12
          spl effective time
          20221012
          spl set id
          cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
          spl version
          2
          substance names
          1. METHYLPREDNISOLONE ACETATE
          uniis
          1. 43502P7F0P
          verification flags
          1. oncology_keyword_candidate_not_clinically_classified
          2. spl_text_not_verified_identical_to_latest_approved_label
          3. individual_indications_not_split_or_reconciled
          4. not_identified_as_original_packager
          5. fda_label_posted_after_spl_effective_date_requires_version_review
          Drugs@FDA application source records
          1. application number
            NDA011757
            payload
            all indexed label documents
            1. Appl No
              011757
              Application Docs Date
              2009-04-16 00:00:00
              Application Docs ID
              10777
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              85
              Submission Type
              SUPPL
            2. Appl No
              011757
              Application Docs Date
              2014-07-09 00:00:00
              Application Docs ID
              10778
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              103
              Submission Type
              SUPPL
            3. Appl No
              011757
              Application Docs Date
              2009-04-16 00:00:00
              Application Docs ID
              33055
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              86
              Submission Type
              SUPPL
            4. Appl No
              011757
              Application Docs Date
              2016-09-09 00:00:00
              Application Docs ID
              45261
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              104
              Submission Type
              SUPPL
            5. Appl No
              011757
              Application Docs Date
              2018-07-25 00:00:00
              Application Docs ID
              54964
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              114
              Submission Type
              SUPPL
            6. Appl No
              011757
              Application Docs Date
              2020-07-29 00:00:00
              Application Docs ID
              64124
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              111
              Submission Type
              SUPPL
            7. Appl No
              011757
              Application Docs Date
              2021-02-16 00:00:00
              Application Docs ID
              66223
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              119
              Submission Type
              SUPPL
            8. Appl No
              011757
              Application Docs Date
              2021-06-04 00:00:00
              Application Docs ID
              67702
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              120
              Submission Type
              SUPPL
            9. Appl No
              011757
              Application Docs Date
              2023-12-21 00:00:00
              Application Docs ID
              77104
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              123
              Submission Type
              SUPPL
            10. Appl No
              011757
              Application Docs Date
              2024-06-06 00:00:00
              Application Docs ID
              78674
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              125
              Submission Type
              SUPPL
            11. Appl No
              011757
              Application Docs Date
              2025-11-07 00:00:00
              Application Docs ID
              84123
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              124
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              125
              Submission Status
              AP
              Submission Status Date
              2024-06-05 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              124
              Submission Status
              AP
              Submission Status Date
              2025-11-04 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              123
              Submission Status
              AP
              Submission Status Date
              2023-12-20 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              120
              Submission Status
              AP
              Submission Status Date
              2021-05-27 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              119
              Submission Status
              AP
              Submission Status Date
              2021-02-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              114
              Submission Status
              AP
              Submission Status Date
              2018-07-24 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              111
              Submission Status
              AP
              Submission Status Date
              2017-03-15 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              104
              Submission Status
              AP
              Submission Status Date
              2016-09-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              103
              Submission Status
              AP
              Submission Status Date
              2014-07-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              102
              Submission Status
              AP
              Submission Status Date
              2014-06-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              98
              Submission Status
              AP
              Submission Status Date
              2013-10-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              011757
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              97
              Submission Status
              AP
              Submission Status Date
              2013-10-07 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA011757
            approval interpretation
            Application linkage and approved submission are not indication-level current approval verification
            current indication status
            not_reconciled
            has approved submission record
            true
            latest approved submission date
            2025-11-04
            latest label selection rule
            max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
            latest posted label documents
            1. Appl No
              011757
              Application Docs Date
              2025-11-07 00:00:00
              Application Docs ID
              84123
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              124
              Submission Type
              SUPPL
            official application record
            Appl No
            011757
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            PFIZER
            openfda application present
            true
            products
            1. Active Ingredient
              METHYLPREDNISOLONE ACETATE
              Appl No
              011757
              Drug Name
              DEPO-MEDROL
              Form
              INJECTABLE;INJECTION
              Product No
              001
              Reference Drug
              1
              Reference Standard
              0
              Strength
              40MG/ML
              marketing status
              1. Prescription
            2. Active Ingredient
              METHYLPREDNISOLONE ACETATE
              Appl No
              011757
              Drug Name
              DEPO-MEDROL
              Form
              INJECTABLE;INJECTION
              Product No
              002
              Reference Drug
              1
              Reference Standard
              1
              Strength
              20MG/ML
              marketing status
              1. Prescription
            3. Active Ingredient
              METHYLPREDNISOLONE ACETATE
              Appl No
              011757
              Drug Name
              DEPO-MEDROL
              Form
              INJECTABLE;INJECTION
              Product No
              004
              Reference Drug
              1
              Reference Standard
              0
              Strength
              80MG/ML
              marketing status
              1. Prescription

          Source passages and status connections

          Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

          Passage 1 · unclassified context
          application numbers
          1. NDA011757
          brand names
          1. Depo-Medrol
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          224
          end exclusive
          true
          exact text
          INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condi
          label id
          ead30b86-564f-7e78-e053-2a95a90ab41c
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-f2d2e58f1a3c4ab41431
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. METHYLPREDNISOLONE ACETATE
          id
          ind-span-f5148354e0abb5859fb8
          label id
          ead30b86-564f-7e78-e053-2a95a90ab41c
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
              source defined aliases
                source span
                end
                24
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE A.
                label id
                ead30b86-564f-7e78-e053-2a95a90ab41c
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                spl effective date
                2022-10-12
                spl set id
                cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                spl version
                2
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                unclear
                Passage 2 · positive indication candidate
                application numbers
                1. NDA011757
                brand names
                1. Depo-Medrol
                classification reasons
                1. explicit_positive_indication_predicate
                2. no_tumor_directed_keyword_in_positive_statement
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                812
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or
                label id
                ead30b86-564f-7e78-e053-2a95a90ab41c
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                start
                0
                current approval status
                not_reconciled
                duplicate text group
                dup-145e0b137fe5e304052e
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. METHYLPREDNISOLONE ACETATE
                id
                ind-span-1c9575848b1c34451fe9
                label id
                ead30b86-564f-7e78-e053-2a95a90ab41c
                positive predicate support span
                end
                306
                end exclusive
                true
                exact text
                is indicated
                label id
                ead30b86-564f-7e78-e053-2a95a90ab41c
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                start
                294
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                    source defined aliases
                      source span
                      end
                      612
                      end exclusive
                      true
                      exact text
                      For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions.
                      label id
                      ead30b86-564f-7e78-e053-2a95a90ab41c
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                      start
                      25
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                      spl effective date
                      2022-10-12
                      spl set id
                      cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                      spl version
                      2
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      non_oncology_or_unclear_candidate
                      Passage 3 · unclassified context
                      application numbers
                      1. NDA011757
                      brand names
                      1. Depo-Medrol
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      979
                      end exclusive
                      true
                      exact text
                      ate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where
                      label id
                      ead30b86-564f-7e78-e053-2a95a90ab41c
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                      start
                      413
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-71a691722f345c2647a3
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. METHYLPREDNISOLONE ACETATE
                      id
                      ind-span-c36f190a9b919d29550d
                      label id
                      ead30b86-564f-7e78-e053-2a95a90ab41c
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                          source defined aliases
                            source span
                            end
                            779
                            end exclusive
                            true
                            exact text
                            Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
                            label id
                            ead30b86-564f-7e78-e053-2a95a90ab41c
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                            start
                            613
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                            spl effective date
                            2022-10-12
                            spl set id
                            cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                            spl version
                            2
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            unclear
                            Passage 4 · unclassified context
                            application numbers
                            1. NDA011757
                            brand names
                            1. Depo-Medrol
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            1363
                            end exclusive
                            true
                            exact text
                            sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) he
                            label id
                            ead30b86-564f-7e78-e053-2a95a90ab41c
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                            start
                            580
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-747162b4c523515493c3
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. METHYLPREDNISOLONE ACETATE
                            id
                            ind-span-35ce48ee66bd959ce9c4
                            label id
                            ead30b86-564f-7e78-e053-2a95a90ab41c
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                source defined aliases
                                  source span
                                  end
                                  1163
                                  end exclusive
                                  true
                                  exact text
                                  Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis.
                                  label id
                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                  start
                                  780
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                  spl effective date
                                  2022-10-12
                                  spl set id
                                  cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                  spl version
                                  2
                                  structured fields status
                                  not_extracted_no_values_inferred_from_mentions
                                  structured indication
                                  age
                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  unclear
                                  Passage 5 · unclassified context
                                  application numbers
                                  1. NDA011757
                                  brand names
                                  1. Depo-Medrol
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  1514
                                  end exclusive
                                  true
                                  exact text
                                  rticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.
                                  label id
                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                  start
                                  964
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-e315c636c3659495b030
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. METHYLPREDNISOLONE ACETATE
                                  id
                                  ind-span-acd56fc535f2d48adea2
                                  label id
                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                      source defined aliases
                                        source span
                                        end
                                        1314
                                        end exclusive
                                        true
                                        exact text
                                        Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
                                        label id
                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                        start
                                        1164
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                        spl effective date
                                        2022-10-12
                                        spl set id
                                        cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                        spl version
                                        2
                                        structured fields status
                                        not_extracted_no_values_inferred_from_mentions
                                        structured indication
                                        age
                                        Source null
                                        approval pathway
                                        Source null
                                        biomarker and test
                                        Source null
                                        disease stage
                                        Source null
                                        limitations
                                        Source null
                                        line
                                        Source null
                                        prior therapy
                                        Source null
                                        regimen
                                        Source null
                                        tumor histology
                                        Source null
                                        use intent
                                        unclear
                                        Passage 6 · unclassified context
                                        application numbers
                                        1. NDA011757
                                        brand names
                                        1. Depo-Medrol
                                        classification reasons
                                        1. no_unambiguous_positive_indication_predicate
                                        clinical review status
                                        pending
                                        content role
                                        unclassified_context
                                        context span
                                        end
                                        1714
                                        end exclusive
                                        true
                                        exact text
                                        sociated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemot
                                        label id
                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                        start
                                        1115
                                        current approval status
                                        not_reconciled
                                        duplicate text group
                                        dup-e9432d861e149a2265c6
                                        extraction review status
                                        automated_candidate_pending_source_review
                                        generic names
                                        1. METHYLPREDNISOLONE ACETATE
                                        id
                                        ind-span-79d2c16e677c2fccec41
                                        label id
                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                        positive predicate support span
                                        Source null
                                        qualifier mentions
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                            source defined aliases
                                              source span
                                              end
                                              1514
                                              end exclusive
                                              true
                                              exact text
                                              Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.
                                              label id
                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                              start
                                              1315
                                              source url
                                              https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                              spl effective date
                                              2022-10-12
                                              spl set id
                                              cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                              spl version
                                              2
                                              structured fields status
                                              not_extracted_no_values_inferred_from_mentions
                                              structured indication
                                              age
                                              Source null
                                              approval pathway
                                              Source null
                                              biomarker and test
                                              Source null
                                              disease stage
                                              Source null
                                              limitations
                                              Source null
                                              line
                                              Source null
                                              prior therapy
                                              Source null
                                              regimen
                                              Source null
                                              tumor histology
                                              Source null
                                              use intent
                                              unclear
                                              Passage 7 · unclassified context
                                              application numbers
                                              1. NDA011757
                                              brand names
                                              1. Depo-Medrol
                                              classification reasons
                                              1. no_unambiguous_positive_indication_predicate
                                              clinical review status
                                              pending
                                              content role
                                              unclassified_context
                                              context span
                                              end
                                              1921
                                              end exclusive
                                              true
                                              exact text
                                              Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tum
                                              label id
                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                              start
                                              1315
                                              current approval status
                                              not_reconciled
                                              duplicate text group
                                              dup-e238b17d597a4979032e
                                              extraction review status
                                              automated_candidate_pending_source_review
                                              generic names
                                              1. METHYLPREDNISOLONE ACETATE
                                              id
                                              ind-span-7a681e54a7871dae6181
                                              label id
                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                              positive predicate support span
                                              Source null
                                              qualifier mentions
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                  source defined aliases
                                                    source span
                                                    end
                                                    1721
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
                                                    label id
                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                    start
                                                    1515
                                                    source url
                                                    https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                    spl effective date
                                                    2022-10-12
                                                    spl set id
                                                    cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                    spl version
                                                    2
                                                    structured fields status
                                                    not_extracted_no_values_inferred_from_mentions
                                                    structured indication
                                                    age
                                                    Source null
                                                    approval pathway
                                                    Source null
                                                    biomarker and test
                                                    Source null
                                                    disease stage
                                                    Source null
                                                    limitations
                                                    Source null
                                                    line
                                                    Source null
                                                    prior therapy
                                                    Source null
                                                    regimen
                                                    Source null
                                                    tumor histology
                                                    Source null
                                                    use intent
                                                    unclear
                                                    Passage 8 · unclassified context
                                                    application numbers
                                                    1. NDA011757
                                                    brand names
                                                    1. Depo-Medrol
                                                    classification reasons
                                                    1. no_unambiguous_positive_indication_predicate
                                                    clinical review status
                                                    pending
                                                    content role
                                                    unclassified_context
                                                    context span
                                                    end
                                                    1998
                                                    end exclusive
                                                    true
                                                    exact text
                                                    aneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arter
                                                    label id
                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                    start
                                                    1522
                                                    current approval status
                                                    not_reconciled
                                                    duplicate text group
                                                    dup-464afadd8118d1ceae4a
                                                    extraction review status
                                                    automated_candidate_pending_source_review
                                                    generic names
                                                    1. METHYLPREDNISOLONE ACETATE
                                                    id
                                                    ind-span-b7e4121f6d3b7af0e358
                                                    label id
                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                    positive predicate support span
                                                    Source null
                                                    qualifier mentions
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
                                                        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                        source defined aliases
                                                          source span
                                                          end
                                                          1798
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Neoplastic Diseases : For palliative management of: leukemias and lymphomas.
                                                          label id
                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                          start
                                                          1722
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                          spl effective date
                                                          2022-10-12
                                                          spl set id
                                                          cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                          spl version
                                                          2
                                                          structured fields status
                                                          not_extracted_no_values_inferred_from_mentions
                                                          structured indication
                                                          age
                                                          Source null
                                                          approval pathway
                                                          Source null
                                                          biomarker and test
                                                          Source null
                                                          disease stage
                                                          Source null
                                                          limitations
                                                          Source null
                                                          line
                                                          Source null
                                                          prior therapy
                                                          Source null
                                                          regimen
                                                          Source null
                                                          tumor histology
                                                          Source null
                                                          use intent
                                                          unclear
                                                          Passage 9 · unclassified context
                                                          application numbers
                                                          1. NDA011757
                                                          brand names
                                                          1. Depo-Medrol
                                                          classification reasons
                                                          1. no_unambiguous_positive_indication_predicate
                                                          clinical review status
                                                          pending
                                                          content role
                                                          unclassified_context
                                                          context span
                                                          end
                                                          2138
                                                          end exclusive
                                                          true
                                                          exact text
                                                          eningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of p
                                                          label id
                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                          start
                                                          1599
                                                          current approval status
                                                          not_reconciled
                                                          duplicate text group
                                                          dup-bfe4996da675278fca6f
                                                          extraction review status
                                                          automated_candidate_pending_source_review
                                                          generic names
                                                          1. METHYLPREDNISOLONE ACETATE
                                                          id
                                                          ind-span-3057bf2127928febc7ff
                                                          label id
                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                          positive predicate support span
                                                          Source null
                                                          qualifier mentions
                                                          1. context exact
                                                            ltiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                            kind
                                                            biomarker
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            1937
                                                            end exclusive
                                                            true
                                                            exact text
                                                            metastatic brain tumor or craniotomy
                                                            label id
                                                            ead30b86-564f-7e78-e053-2a95a90ab41c
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                            start
                                                            1901
                                                          2. context exact
                                                            ltiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                            kind
                                                            stage_or_setting
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            1937
                                                            end exclusive
                                                            true
                                                            exact text
                                                            metastatic brain tumor or craniotomy
                                                            label id
                                                            ead30b86-564f-7e78-e053-2a95a90ab41c
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                            start
                                                            1901
                                                          regulatory links
                                                            schema version
                                                            0.1.0
                                                            source batch sha256
                                                            24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                            source defined aliases
                                                              source span
                                                              end
                                                              1938
                                                              end exclusive
                                                              true
                                                              exact text
                                                              Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                              label id
                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                              start
                                                              1799
                                                              source url
                                                              https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                              spl effective date
                                                              2022-10-12
                                                              spl set id
                                                              cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                              spl version
                                                              2
                                                              structured fields status
                                                              not_extracted_no_values_inferred_from_mentions
                                                              structured indication
                                                              age
                                                              Source null
                                                              approval pathway
                                                              Source null
                                                              biomarker and test
                                                              Source null
                                                              disease stage
                                                              Source null
                                                              limitations
                                                              Source null
                                                              line
                                                              Source null
                                                              prior therapy
                                                              Source null
                                                              regimen
                                                              Source null
                                                              tumor histology
                                                              Source null
                                                              use intent
                                                              unclear
                                                              Passage 10 · unclassified context
                                                              application numbers
                                                              1. NDA011757
                                                              brand names
                                                              1. Depo-Medrol
                                                              classification reasons
                                                              1. no_unambiguous_positive_indication_predicate
                                                              clinical review status
                                                              pending
                                                              content role
                                                              unclassified_context
                                                              context span
                                                              end
                                                              2284
                                                              end exclusive
                                                              true
                                                              exact text
                                                              es : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated p
                                                              label id
                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                              start
                                                              1739
                                                              current approval status
                                                              not_reconciled
                                                              duplicate text group
                                                              dup-cb0ee41fe2d925e62766
                                                              extraction review status
                                                              automated_candidate_pending_source_review
                                                              generic names
                                                              1. METHYLPREDNISOLONE ACETATE
                                                              id
                                                              ind-span-7113d67516c48f14e1dc
                                                              label id
                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                              positive predicate support span
                                                              Source null
                                                              qualifier mentions
                                                                regulatory links
                                                                  schema version
                                                                  0.1.0
                                                                  source batch sha256
                                                                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                  source defined aliases
                                                                    source span
                                                                    end
                                                                    2084
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids.
                                                                    label id
                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                    start
                                                                    1939
                                                                    source url
                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                    spl effective date
                                                                    2022-10-12
                                                                    spl set id
                                                                    cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                    spl version
                                                                    2
                                                                    structured fields status
                                                                    not_extracted_no_values_inferred_from_mentions
                                                                    structured indication
                                                                    age
                                                                    Source null
                                                                    approval pathway
                                                                    Source null
                                                                    biomarker and test
                                                                    Source null
                                                                    disease stage
                                                                    Source null
                                                                    limitations
                                                                    Source null
                                                                    line
                                                                    Source null
                                                                    prior therapy
                                                                    Source null
                                                                    regimen
                                                                    Source null
                                                                    tumor histology
                                                                    Source null
                                                                    use intent
                                                                    unclear
                                                                    Passage 11 · unclassified context
                                                                    application numbers
                                                                    1. NDA011757
                                                                    brand names
                                                                    1. Depo-Medrol
                                                                    classification reasons
                                                                    1. no_unambiguous_positive_indication_predicate
                                                                    clinical review status
                                                                    pending
                                                                    content role
                                                                    unclassified_context
                                                                    context span
                                                                    end
                                                                    2418
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, sympto
                                                                    label id
                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                    start
                                                                    1885
                                                                    current approval status
                                                                    not_reconciled
                                                                    duplicate text group
                                                                    dup-fa04153d63cdfb28cf42
                                                                    extraction review status
                                                                    automated_candidate_pending_source_review
                                                                    generic names
                                                                    1. METHYLPREDNISOLONE ACETATE
                                                                    id
                                                                    ind-span-1da8629b331d0cb58a65
                                                                    label id
                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                    positive predicate support span
                                                                    Source null
                                                                    qualifier mentions
                                                                      regulatory links
                                                                        schema version
                                                                        0.1.0
                                                                        source batch sha256
                                                                        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                        source defined aliases
                                                                          source span
                                                                          end
                                                                          2218
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.
                                                                          label id
                                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                          start
                                                                          2085
                                                                          source url
                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                          spl effective date
                                                                          2022-10-12
                                                                          spl set id
                                                                          cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                          spl version
                                                                          2
                                                                          structured fields status
                                                                          not_extracted_no_values_inferred_from_mentions
                                                                          structured indication
                                                                          age
                                                                          Source null
                                                                          approval pathway
                                                                          Source null
                                                                          biomarker and test
                                                                          Source null
                                                                          disease stage
                                                                          Source null
                                                                          limitations
                                                                          Source null
                                                                          line
                                                                          Source null
                                                                          prior therapy
                                                                          Source null
                                                                          regimen
                                                                          Source null
                                                                          tumor histology
                                                                          Source null
                                                                          use intent
                                                                          unclear
                                                                          Passage 12 · unclassified context
                                                                          application numbers
                                                                          1. NDA011757
                                                                          brand names
                                                                          1. Depo-Medrol
                                                                          classification reasons
                                                                          1. no_unambiguous_positive_indication_predicate
                                                                          clinical review status
                                                                          pending
                                                                          content role
                                                                          unclassified_context
                                                                          context span
                                                                          end
                                                                          2636
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing sp
                                                                          label id
                                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                          start
                                                                          2019
                                                                          current approval status
                                                                          not_reconciled
                                                                          duplicate text group
                                                                          dup-a5edfccf9ad763cdaf9b
                                                                          extraction review status
                                                                          automated_candidate_pending_source_review
                                                                          generic names
                                                                          1. METHYLPREDNISOLONE ACETATE
                                                                          id
                                                                          ind-span-d894890e9f7f69a4ff2c
                                                                          label id
                                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                          positive predicate support span
                                                                          Source null
                                                                          qualifier mentions
                                                                            regulatory links
                                                                              schema version
                                                                              0.1.0
                                                                              source batch sha256
                                                                              24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                              source defined aliases
                                                                                source span
                                                                                end
                                                                                2436
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
                                                                                label id
                                                                                ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                start
                                                                                2219
                                                                                source url
                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                spl effective date
                                                                                2022-10-12
                                                                                spl set id
                                                                                cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                spl version
                                                                                2
                                                                                structured fields status
                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                structured indication
                                                                                age
                                                                                Source null
                                                                                approval pathway
                                                                                Source null
                                                                                biomarker and test
                                                                                Source null
                                                                                disease stage
                                                                                Source null
                                                                                limitations
                                                                                Source null
                                                                                line
                                                                                Source null
                                                                                prior therapy
                                                                                Source null
                                                                                regimen
                                                                                Source null
                                                                                tumor histology
                                                                                Source null
                                                                                use intent
                                                                                unclear
                                                                                Passage 13 · unclassified context
                                                                                application numbers
                                                                                1. NDA011757
                                                                                brand names
                                                                                1. Depo-Medrol
                                                                                classification reasons
                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                clinical review status
                                                                                pending
                                                                                content role
                                                                                unclassified_context
                                                                                context span
                                                                                end
                                                                                2988
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                es : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive thera
                                                                                label id
                                                                                ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                start
                                                                                2237
                                                                                current approval status
                                                                                not_reconciled
                                                                                duplicate text group
                                                                                dup-87fde2dbd863f05e3d08
                                                                                extraction review status
                                                                                automated_candidate_pending_source_review
                                                                                generic names
                                                                                1. METHYLPREDNISOLONE ACETATE
                                                                                id
                                                                                ind-span-5b23f0ae0ea2e1ca8876
                                                                                label id
                                                                                ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                positive predicate support span
                                                                                Source null
                                                                                qualifier mentions
                                                                                  regulatory links
                                                                                    schema version
                                                                                    0.1.0
                                                                                    source batch sha256
                                                                                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                    source defined aliases
                                                                                      source span
                                                                                      end
                                                                                      2788
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
                                                                                      label id
                                                                                      ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                      start
                                                                                      2437
                                                                                      source url
                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                      spl effective date
                                                                                      2022-10-12
                                                                                      spl set id
                                                                                      cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                      spl version
                                                                                      2
                                                                                      structured fields status
                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                      structured indication
                                                                                      age
                                                                                      Source null
                                                                                      approval pathway
                                                                                      Source null
                                                                                      biomarker and test
                                                                                      Source null
                                                                                      disease stage
                                                                                      Source null
                                                                                      limitations
                                                                                      Source null
                                                                                      line
                                                                                      Source null
                                                                                      prior therapy
                                                                                      Source null
                                                                                      regimen
                                                                                      Source null
                                                                                      tumor histology
                                                                                      Source null
                                                                                      use intent
                                                                                      unclear
                                                                                      Passage 14 · unclassified context
                                                                                      application numbers
                                                                                      1. NDA011757
                                                                                      brand names
                                                                                      1. Depo-Medrol
                                                                                      classification reasons
                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                      clinical review status
                                                                                      pending
                                                                                      content role
                                                                                      unclassified_context
                                                                                      context span
                                                                                      end
                                                                                      3074
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      hritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerb
                                                                                      label id
                                                                                      ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                      start
                                                                                      2589
                                                                                      current approval status
                                                                                      not_reconciled
                                                                                      duplicate text group
                                                                                      dup-720395f11fdcddf6e991
                                                                                      extraction review status
                                                                                      automated_candidate_pending_source_review
                                                                                      generic names
                                                                                      1. METHYLPREDNISOLONE ACETATE
                                                                                      id
                                                                                      ind-span-4a6592603744f1de1de8
                                                                                      label id
                                                                                      ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                      positive predicate support span
                                                                                      Source null
                                                                                      qualifier mentions
                                                                                        regulatory links
                                                                                          schema version
                                                                                          0.1.0
                                                                                          source batch sha256
                                                                                          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                          source defined aliases
                                                                                            source span
                                                                                            end
                                                                                            2874
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
                                                                                            label id
                                                                                            ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                            start
                                                                                            2789
                                                                                            source url
                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                            spl effective date
                                                                                            2022-10-12
                                                                                            spl set id
                                                                                            cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                            spl version
                                                                                            2
                                                                                            structured fields status
                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                            structured indication
                                                                                            age
                                                                                            Source null
                                                                                            approval pathway
                                                                                            Source null
                                                                                            biomarker and test
                                                                                            Source null
                                                                                            disease stage
                                                                                            Source null
                                                                                            limitations
                                                                                            Source null
                                                                                            line
                                                                                            Source null
                                                                                            prior therapy
                                                                                            Source null
                                                                                            regimen
                                                                                            Source null
                                                                                            tumor histology
                                                                                            Source null
                                                                                            use intent
                                                                                            unclear
                                                                                            Passage 15 · unclassified context
                                                                                            application numbers
                                                                                            1. NDA011757
                                                                                            brand names
                                                                                            1. Depo-Medrol
                                                                                            classification reasons
                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                            clinical review status
                                                                                            pending
                                                                                            content role
                                                                                            unclassified_context
                                                                                            context span
                                                                                            end
                                                                                            3077
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            oid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbati
                                                                                            label id
                                                                                            ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                            start
                                                                                            2675
                                                                                            current approval status
                                                                                            not_reconciled
                                                                                            duplicate text group
                                                                                            dup-da5bac15cc6f6b30a2a3
                                                                                            extraction review status
                                                                                            automated_candidate_pending_source_review
                                                                                            generic names
                                                                                            1. METHYLPREDNISOLONE ACETATE
                                                                                            id
                                                                                            ind-span-e66268d782517a94edd3
                                                                                            label id
                                                                                            ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                            positive predicate support span
                                                                                            Source null
                                                                                            qualifier mentions
                                                                                              regulatory links
                                                                                                schema version
                                                                                                0.1.0
                                                                                                source batch sha256
                                                                                                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                source defined aliases
                                                                                                  source span
                                                                                                  end
                                                                                                  2877
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  B.
                                                                                                  label id
                                                                                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                  start
                                                                                                  2875
                                                                                                  source url
                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                                  spl effective date
                                                                                                  2022-10-12
                                                                                                  spl set id
                                                                                                  cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                                  spl version
                                                                                                  2
                                                                                                  structured fields status
                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                  structured indication
                                                                                                  age
                                                                                                  Source null
                                                                                                  approval pathway
                                                                                                  Source null
                                                                                                  biomarker and test
                                                                                                  Source null
                                                                                                  disease stage
                                                                                                  Source null
                                                                                                  limitations
                                                                                                  Source null
                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
                                                                                                  Source null
                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  unclear
                                                                                                  Passage 16 · positive indication candidate
                                                                                                  application numbers
                                                                                                  1. NDA011757
                                                                                                  brand names
                                                                                                  1. Depo-Medrol
                                                                                                  classification reasons
                                                                                                  1. explicit_positive_indication_predicate
                                                                                                  2. no_tumor_directed_keyword_in_positive_statement
                                                                                                  3. positive_statement_also_contains_qualification_review_required
                                                                                                  clinical review status
                                                                                                  pending
                                                                                                  content role
                                                                                                  positive_indication_candidate
                                                                                                  context span
                                                                                                  end
                                                                                                  3434
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions o
                                                                                                  label id
                                                                                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                  start
                                                                                                  2678
                                                                                                  current approval status
                                                                                                  not_reconciled
                                                                                                  duplicate text group
                                                                                                  dup-c7fe4cf6ebad404a0147
                                                                                                  extraction review status
                                                                                                  automated_candidate_pending_source_review
                                                                                                  generic names
                                                                                                  1. METHYLPREDNISOLONE ACETATE
                                                                                                  id
                                                                                                  ind-span-c6bfe1731639d067bbe0
                                                                                                  label id
                                                                                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                  positive predicate support span
                                                                                                  end
                                                                                                  2968
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  is indicated
                                                                                                  label id
                                                                                                  ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                  start
                                                                                                  2956
                                                                                                  qualifier mentions
                                                                                                    regulatory links
                                                                                                      schema version
                                                                                                      0.1.0
                                                                                                      source batch sha256
                                                                                                      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                      source defined aliases
                                                                                                        source span
                                                                                                        end
                                                                                                        3234
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        For Intra-articular Or Soft Tissue Administration (See WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
                                                                                                        label id
                                                                                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                        start
                                                                                                        2878
                                                                                                        source url
                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                                        spl effective date
                                                                                                        2022-10-12
                                                                                                        spl set id
                                                                                                        cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                                        spl version
                                                                                                        2
                                                                                                        structured fields status
                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                        structured indication
                                                                                                        age
                                                                                                        Source null
                                                                                                        approval pathway
                                                                                                        Source null
                                                                                                        biomarker and test
                                                                                                        Source null
                                                                                                        disease stage
                                                                                                        Source null
                                                                                                        limitations
                                                                                                        Source null
                                                                                                        line
                                                                                                        Source null
                                                                                                        prior therapy
                                                                                                        Source null
                                                                                                        regimen
                                                                                                        Source null
                                                                                                        tumor histology
                                                                                                        Source null
                                                                                                        use intent
                                                                                                        non_oncology_or_unclear_candidate
                                                                                                        Passage 17 · unclassified context
                                                                                                        application numbers
                                                                                                        1. NDA011757
                                                                                                        brand names
                                                                                                        1. Depo-Medrol
                                                                                                        classification reasons
                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                        clinical review status
                                                                                                        pending
                                                                                                        content role
                                                                                                        unclassified_context
                                                                                                        context span
                                                                                                        end
                                                                                                        3437
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        atient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of g
                                                                                                        label id
                                                                                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                        start
                                                                                                        3035
                                                                                                        current approval status
                                                                                                        not_reconciled
                                                                                                        duplicate text group
                                                                                                        dup-60264bec3ecd7e116342
                                                                                                        extraction review status
                                                                                                        automated_candidate_pending_source_review
                                                                                                        generic names
                                                                                                        1. METHYLPREDNISOLONE ACETATE
                                                                                                        id
                                                                                                        ind-span-74bb1097f32b6ea834cd
                                                                                                        label id
                                                                                                        ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                        positive predicate support span
                                                                                                        Source null
                                                                                                        qualifier mentions
                                                                                                          regulatory links
                                                                                                            schema version
                                                                                                            0.1.0
                                                                                                            source batch sha256
                                                                                                            24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                            source defined aliases
                                                                                                              source span
                                                                                                              end
                                                                                                              3237
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              C.
                                                                                                              label id
                                                                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                              start
                                                                                                              3235
                                                                                                              source url
                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                                              spl effective date
                                                                                                              2022-10-12
                                                                                                              spl set id
                                                                                                              cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                                              spl version
                                                                                                              2
                                                                                                              structured fields status
                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                              structured indication
                                                                                                              age
                                                                                                              Source null
                                                                                                              approval pathway
                                                                                                              Source null
                                                                                                              biomarker and test
                                                                                                              Source null
                                                                                                              disease stage
                                                                                                              Source null
                                                                                                              limitations
                                                                                                              Source null
                                                                                                              line
                                                                                                              Source null
                                                                                                              prior therapy
                                                                                                              Source null
                                                                                                              regimen
                                                                                                              Source null
                                                                                                              tumor histology
                                                                                                              Source null
                                                                                                              use intent
                                                                                                              unclear
                                                                                                              Passage 18 · positive indication candidate
                                                                                                              application numbers
                                                                                                              1. NDA011757
                                                                                                              brand names
                                                                                                              1. Depo-Medrol
                                                                                                              classification reasons
                                                                                                              1. explicit_positive_indication_predicate
                                                                                                              2. no_tumor_directed_keyword_in_positive_statement
                                                                                                              clinical review status
                                                                                                              pending
                                                                                                              content role
                                                                                                              positive_indication_candidate
                                                                                                              context span
                                                                                                              end
                                                                                                              3659
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              ent over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                              label id
                                                                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                              start
                                                                                                              3038
                                                                                                              current approval status
                                                                                                              not_reconciled
                                                                                                              duplicate text group
                                                                                                              dup-0d6048e643cf75fe7515
                                                                                                              extraction review status
                                                                                                              automated_candidate_pending_source_review
                                                                                                              generic names
                                                                                                              1. METHYLPREDNISOLONE ACETATE
                                                                                                              id
                                                                                                              ind-span-7259ce25da8aeb6ddae8
                                                                                                              label id
                                                                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                              positive predicate support span
                                                                                                              end
                                                                                                              3295
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              is indicated
                                                                                                              label id
                                                                                                              ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                              start
                                                                                                              3283
                                                                                                              qualifier mentions
                                                                                                                regulatory links
                                                                                                                  schema version
                                                                                                                  0.1.0
                                                                                                                  source batch sha256
                                                                                                                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                                  source defined aliases
                                                                                                                    source span
                                                                                                                    end
                                                                                                                    3572
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum.
                                                                                                                    label id
                                                                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                                    start
                                                                                                                    3238
                                                                                                                    source url
                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                                                    spl effective date
                                                                                                                    2022-10-12
                                                                                                                    spl set id
                                                                                                                    cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                                                    spl version
                                                                                                                    2
                                                                                                                    structured fields status
                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                    structured indication
                                                                                                                    age
                                                                                                                    Source null
                                                                                                                    approval pathway
                                                                                                                    Source null
                                                                                                                    biomarker and test
                                                                                                                    Source null
                                                                                                                    disease stage
                                                                                                                    Source null
                                                                                                                    limitations
                                                                                                                    Source null
                                                                                                                    line
                                                                                                                    Source null
                                                                                                                    prior therapy
                                                                                                                    Source null
                                                                                                                    regimen
                                                                                                                    Source null
                                                                                                                    tumor histology
                                                                                                                    Source null
                                                                                                                    use intent
                                                                                                                    non_oncology_or_unclear_candidate
                                                                                                                    Passage 19 · unclassified context
                                                                                                                    application numbers
                                                                                                                    1. NDA011757
                                                                                                                    brand names
                                                                                                                    1. Depo-Medrol
                                                                                                                    classification reasons
                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                    clinical review status
                                                                                                                    pending
                                                                                                                    content role
                                                                                                                    unclassified_context
                                                                                                                    context span
                                                                                                                    end
                                                                                                                    3659
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    s, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                                    label id
                                                                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                                    start
                                                                                                                    3373
                                                                                                                    current approval status
                                                                                                                    not_reconciled
                                                                                                                    duplicate text group
                                                                                                                    dup-e968b55544805c82065c
                                                                                                                    extraction review status
                                                                                                                    automated_candidate_pending_source_review
                                                                                                                    generic names
                                                                                                                    1. METHYLPREDNISOLONE ACETATE
                                                                                                                    id
                                                                                                                    ind-span-aa2992ecfb862732c0dd
                                                                                                                    label id
                                                                                                                    ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                                    positive predicate support span
                                                                                                                    Source null
                                                                                                                    qualifier mentions
                                                                                                                      regulatory links
                                                                                                                        schema version
                                                                                                                        0.1.0
                                                                                                                        source batch sha256
                                                                                                                        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                                        source defined aliases
                                                                                                                          source span
                                                                                                                          end
                                                                                                                          3659
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                                          label id
                                                                                                                          ead30b86-564f-7e78-e053-2a95a90ab41c
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          5f1e7978237a3669594c0dccf7c0648c8fb13590cdf1fc2814ad4aeed2e09770
                                                                                                                          start
                                                                                                                          3573
                                                                                                                          source url
                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22ead30b86-564f-7e78-e053-2a95a90ab41c%22
                                                                                                                          spl effective date
                                                                                                                          2022-10-12
                                                                                                                          spl set id
                                                                                                                          cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6
                                                                                                                          spl version
                                                                                                                          2
                                                                                                                          structured fields status
                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                          structured indication
                                                                                                                          age
                                                                                                                          Source null
                                                                                                                          approval pathway
                                                                                                                          Source null
                                                                                                                          biomarker and test
                                                                                                                          Source null
                                                                                                                          disease stage
                                                                                                                          Source null
                                                                                                                          limitations
                                                                                                                          Source null
                                                                                                                          line
                                                                                                                          Source null
                                                                                                                          prior therapy
                                                                                                                          Source null
                                                                                                                          regimen
                                                                                                                          Source null
                                                                                                                          tumor histology
                                                                                                                          Source null
                                                                                                                          use intent
                                                                                                                          unclear

                                                                                                                          Preserved source evidence · Not medical advice