Skip to content
← Back to this collection

LABELS · 267dd735-f800-4735-ba1c-d39d00f0cee5

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
2026-01-21
Captured
2026-09-09T23:37:42.544548+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, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, 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, nonsuppurative 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 : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and 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=823b0010-2b57-4e76-b5ac-4a8c2963438f
    generic names
    1. METHYLPREDNISOLONE ACETATE
    id
    267dd735-f800-4735-ba1c-d39d00f0cee5
    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, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, 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, nonsuppurative 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 : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and 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
      1. true
      manufacturer names
      1. Pharmacia & Upjohn Company LLC
      matched search terms
      1. cancer
      2. lymphomas
      3. tumor
      4. tumors
      package ndcs
      1. 0009-0274-01
      2. 0009-0280-02
      3. 0009-0280-51
      4. 0009-0280-03
      5. 0009-0280-52
      6. 0009-0306-02
      7. 0009-0306-12
      product ndcs
      1. 0009-0274
      2. 0009-0280
      3. 0009-0306
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRALESIONAL
        2. INTRAMUSCULAR
        3. INTRASYNOVIAL
        4. SOFT TISSUE
        rxcuis
        1. 1358510
        2. 1358512
        3. 1358610
        4. 1358612
        5. 1358617
        6. 1358619
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
        spl effective date
        2026-01-21
        spl effective time
        20260121
        spl set id
        823b0010-2b57-4e76-b5ac-4a8c2963438f
        spl version
        22
        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
        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
        267dd735-f800-4735-ba1c-d39d00f0cee5
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-0937f2a029cc7cf34ec7
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. METHYLPREDNISOLONE ACETATE
        id
        ind-span-e6e65a4038f9e9ac9d33
        label id
        267dd735-f800-4735-ba1c-d39d00f0cee5
        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
            source defined aliases
              source span
              end
              24
              end exclusive
              true
              exact text
              INDICATIONS AND USAGE A.
              label id
              267dd735-f800-4735-ba1c-d39d00f0cee5
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
              spl effective date
              2026-01-21
              spl set id
              823b0010-2b57-4e76-b5ac-4a8c2963438f
              spl version
              22
              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
              771
              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, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary
              label id
              267dd735-f800-4735-ba1c-d39d00f0cee5
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
              start
              0
              current approval status
              not_reconciled
              duplicate text group
              dup-4fbe17870aa77d3f5e83
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. METHYLPREDNISOLONE ACETATE
              id
              ind-span-b025499cc125bda87391
              label id
              267dd735-f800-4735-ba1c-d39d00f0cee5
              positive predicate support span
              end
              306
              end exclusive
              true
              exact text
              is indicated
              label id
              267dd735-f800-4735-ba1c-d39d00f0cee5
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
              start
              294
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                  source defined aliases
                    source span
                    end
                    571
                    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, serum sickness, transfusion reactions.
                    label id
                    267dd735-f800-4735-ba1c-d39d00f0cee5
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                    start
                    25
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                    spl effective date
                    2026-01-21
                    spl set id
                    823b0010-2b57-4e76-b5ac-4a8c2963438f
                    spl version
                    22
                    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
                    940
                    end exclusive
                    true
                    exact text
                    allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, 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
                    267dd735-f800-4735-ba1c-d39d00f0cee5
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                    start
                    372
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-b9f4dd17f0b1e957bea2
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. METHYLPREDNISOLONE ACETATE
                    id
                    ind-span-9ddda670a238cfc9a683
                    label id
                    267dd735-f800-4735-ba1c-d39d00f0cee5
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                        source defined aliases
                          source span
                          end
                          740
                          end exclusive
                          true
                          exact text
                          Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
                          label id
                          267dd735-f800-4735-ba1c-d39d00f0cee5
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                          start
                          572
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                          spl effective date
                          2026-01-21
                          spl set id
                          823b0010-2b57-4e76-b5ac-4a8c2963438f
                          spl version
                          22
                          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
                          1325
                          end exclusive
                          true
                          exact text
                          ckness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, 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, nonsuppurative 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
                          267dd735-f800-4735-ba1c-d39d00f0cee5
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                          start
                          541
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-74e50253ff66a1385818
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. METHYLPREDNISOLONE ACETATE
                          id
                          ind-span-e60c96ff289be686f0da
                          label id
                          267dd735-f800-4735-ba1c-d39d00f0cee5
                          positive predicate support span
                          Source null
                          qualifier mentions
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                              source defined aliases
                                source span
                                end
                                1125
                                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, nonsuppurative thyroiditis.
                                label id
                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                start
                                741
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                spl effective date
                                2026-01-21
                                spl set id
                                823b0010-2b57-4e76-b5ac-4a8c2963438f
                                spl version
                                22
                                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
                                1476
                                end exclusive
                                true
                                exact text
                                ticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative 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
                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                start
                                926
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-32c025fefe7551d6002e
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. METHYLPREDNISOLONE ACETATE
                                id
                                ind-span-14f82a2e7cc66734a266
                                label id
                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                positive predicate support span
                                Source null
                                qualifier mentions
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                    source defined aliases
                                      source span
                                      end
                                      1276
                                      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
                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                      start
                                      1126
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                      spl effective date
                                      2026-01-21
                                      spl set id
                                      823b0010-2b57-4e76-b5ac-4a8c2963438f
                                      spl version
                                      22
                                      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
                                      1676
                                      end exclusive
                                      true
                                      exact text
                                      ociated with cancer, nonsuppurative 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
                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                      start
                                      1077
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-3a89a03fb929943e3ab3
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. METHYLPREDNISOLONE ACETATE
                                      id
                                      ind-span-23a7ed5c18bb0f1af70d
                                      label id
                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                          source defined aliases
                                            source span
                                            end
                                            1476
                                            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
                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                            start
                                            1277
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                            spl effective date
                                            2026-01-21
                                            spl set id
                                            823b0010-2b57-4e76-b5ac-4a8c2963438f
                                            spl version
                                            22
                                            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
                                            1883
                                            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 : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Symp
                                            label id
                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                            start
                                            1277
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-d4783cbafc27192e1a89
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. METHYLPREDNISOLONE ACETATE
                                            id
                                            ind-span-76c56ac62938aa58f834
                                            label id
                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                              regulatory links
                                                schema version
                                                0.1.0
                                                source batch sha256
                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                source defined aliases
                                                  source span
                                                  end
                                                  1683
                                                  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
                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                  start
                                                  1477
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                  spl effective date
                                                  2026-01-21
                                                  spl set id
                                                  823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                  spl version
                                                  22
                                                  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
                                                  1959
                                                  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 : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory cond
                                                  label id
                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                  start
                                                  1484
                                                  current approval status
                                                  not_reconciled
                                                  duplicate text group
                                                  dup-b3ff21b8dbe78a727d52
                                                  extraction review status
                                                  automated_candidate_pending_source_review
                                                  generic names
                                                  1. METHYLPREDNISOLONE ACETATE
                                                  id
                                                  ind-span-5fa8bc4737966813e5e7
                                                  label id
                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                  positive predicate support span
                                                  Source null
                                                  qualifier mentions
                                                    regulatory links
                                                      schema version
                                                      0.1.0
                                                      source batch sha256
                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                      source defined aliases
                                                        source span
                                                        end
                                                        1759
                                                        end exclusive
                                                        true
                                                        exact text
                                                        Neoplastic Diseases : For palliative management of leukemias and lymphomas.
                                                        label id
                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                        start
                                                        1684
                                                        source url
                                                        https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                        spl effective date
                                                        2026-01-21
                                                        spl set id
                                                        823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                        spl version
                                                        22
                                                        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
                                                        2056
                                                        end exclusive
                                                        true
                                                        exact text
                                                        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 : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission
                                                        label id
                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                        start
                                                        1560
                                                        current approval status
                                                        not_reconciled
                                                        duplicate text group
                                                        dup-4fd41b689e0be64fdf7e
                                                        extraction review status
                                                        automated_candidate_pending_source_review
                                                        generic names
                                                        1. METHYLPREDNISOLONE ACETATE
                                                        id
                                                        ind-span-6622741e08f59cb2fd81
                                                        label id
                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                        positive predicate support span
                                                        Source null
                                                        qualifier mentions
                                                        1. context exact
                                                          Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                          kind
                                                          biomarker
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          1855
                                                          end exclusive
                                                          true
                                                          exact text
                                                          metastatic brain tumor or craniotomy
                                                          label id
                                                          267dd735-f800-4735-ba1c-d39d00f0cee5
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                          start
                                                          1819
                                                        2. context exact
                                                          Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                          kind
                                                          stage_or_setting
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          1855
                                                          end exclusive
                                                          true
                                                          exact text
                                                          metastatic brain tumor or craniotomy
                                                          label id
                                                          267dd735-f800-4735-ba1c-d39d00f0cee5
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                          start
                                                          1819
                                                        regulatory links
                                                          schema version
                                                          0.1.0
                                                          source batch sha256
                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                          source defined aliases
                                                            source span
                                                            end
                                                            1856
                                                            end exclusive
                                                            true
                                                            exact text
                                                            Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                            label id
                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                            start
                                                            1760
                                                            source url
                                                            https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                            spl effective date
                                                            2026-01-21
                                                            spl set id
                                                            823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                            spl version
                                                            22
                                                            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
                                                            2206
                                                            end exclusive
                                                            true
                                                            exact text
                                                            ituberculous chemotherapy. Neoplastic Diseases : For palliative management of leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and 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
                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                            start
                                                            1657
                                                            current approval status
                                                            not_reconciled
                                                            duplicate text group
                                                            dup-bec185e685dda6c8627f
                                                            extraction review status
                                                            automated_candidate_pending_source_review
                                                            generic names
                                                            1. METHYLPREDNISOLONE ACETATE
                                                            id
                                                            ind-span-0e5ad9c8b67ffc8d2d74
                                                            label id
                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                            positive predicate support span
                                                            Source null
                                                            qualifier mentions
                                                              regulatory links
                                                                schema version
                                                                0.1.0
                                                                source batch sha256
                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                source defined aliases
                                                                  source span
                                                                  end
                                                                  2006
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
                                                                  label id
                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                  start
                                                                  1857
                                                                  source url
                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                  spl effective date
                                                                  2026-01-21
                                                                  spl set id
                                                                  823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                  spl version
                                                                  22
                                                                  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
                                                                  2340
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis and 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
                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                  start
                                                                  1807
                                                                  current approval status
                                                                  not_reconciled
                                                                  duplicate text group
                                                                  dup-569e7b97668b4d849aff
                                                                  extraction review status
                                                                  automated_candidate_pending_source_review
                                                                  generic names
                                                                  1. METHYLPREDNISOLONE ACETATE
                                                                  id
                                                                  ind-span-10d85b5e307502b699a3
                                                                  label id
                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                  positive predicate support span
                                                                  Source null
                                                                  qualifier mentions
                                                                    regulatory links
                                                                      schema version
                                                                      0.1.0
                                                                      source batch sha256
                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                      source defined aliases
                                                                        source span
                                                                        end
                                                                        2140
                                                                        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
                                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                        start
                                                                        2007
                                                                        source url
                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                        spl effective date
                                                                        2026-01-21
                                                                        spl set id
                                                                        823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                        spl version
                                                                        22
                                                                        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
                                                                        2558
                                                                        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
                                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                        start
                                                                        1941
                                                                        current approval status
                                                                        not_reconciled
                                                                        duplicate text group
                                                                        dup-c139b7eb2205be4e791b
                                                                        extraction review status
                                                                        automated_candidate_pending_source_review
                                                                        generic names
                                                                        1. METHYLPREDNISOLONE ACETATE
                                                                        id
                                                                        ind-span-a5de8a7682db875d0391
                                                                        label id
                                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                        positive predicate support span
                                                                        Source null
                                                                        qualifier mentions
                                                                          regulatory links
                                                                            schema version
                                                                            0.1.0
                                                                            source batch sha256
                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                            source defined aliases
                                                                              source span
                                                                              end
                                                                              2358
                                                                              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
                                                                              267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                              start
                                                                              2141
                                                                              source url
                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                              spl effective date
                                                                              2026-01-21
                                                                              spl set id
                                                                              823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                              spl version
                                                                              22
                                                                              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
                                                                              2910
                                                                              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
                                                                              267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                              start
                                                                              2159
                                                                              current approval status
                                                                              not_reconciled
                                                                              duplicate text group
                                                                              dup-3d32af4f68752366028c
                                                                              extraction review status
                                                                              automated_candidate_pending_source_review
                                                                              generic names
                                                                              1. METHYLPREDNISOLONE ACETATE
                                                                              id
                                                                              ind-span-4070b5ec6ba4702151e9
                                                                              label id
                                                                              267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                              positive predicate support span
                                                                              Source null
                                                                              qualifier mentions
                                                                                regulatory links
                                                                                  schema version
                                                                                  0.1.0
                                                                                  source batch sha256
                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                  source defined aliases
                                                                                    source span
                                                                                    end
                                                                                    2710
                                                                                    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
                                                                                    267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                    offset unit
                                                                                    unicode_code_points
                                                                                    source array index
                                                                                    0
                                                                                    source field
                                                                                    indications_and_usage_exact
                                                                                    source text sha256
                                                                                    f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                    start
                                                                                    2359
                                                                                    source url
                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                    spl effective date
                                                                                    2026-01-21
                                                                                    spl set id
                                                                                    823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                    spl version
                                                                                    22
                                                                                    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
                                                                                    2996
                                                                                    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
                                                                                    267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                    offset unit
                                                                                    unicode_code_points
                                                                                    source array index
                                                                                    0
                                                                                    source field
                                                                                    indications_and_usage_exact
                                                                                    source text sha256
                                                                                    f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                    start
                                                                                    2511
                                                                                    current approval status
                                                                                    not_reconciled
                                                                                    duplicate text group
                                                                                    dup-81aa6ee5f11dc121c9b7
                                                                                    extraction review status
                                                                                    automated_candidate_pending_source_review
                                                                                    generic names
                                                                                    1. METHYLPREDNISOLONE ACETATE
                                                                                    id
                                                                                    ind-span-5bd6947b0b48031cff77
                                                                                    label id
                                                                                    267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                    positive predicate support span
                                                                                    Source null
                                                                                    qualifier mentions
                                                                                      regulatory links
                                                                                        schema version
                                                                                        0.1.0
                                                                                        source batch sha256
                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                        source defined aliases
                                                                                          source span
                                                                                          end
                                                                                          2796
                                                                                          end exclusive
                                                                                          true
                                                                                          exact text
                                                                                          For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
                                                                                          label id
                                                                                          267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                          offset unit
                                                                                          unicode_code_points
                                                                                          source array index
                                                                                          0
                                                                                          source field
                                                                                          indications_and_usage_exact
                                                                                          source text sha256
                                                                                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                          start
                                                                                          2711
                                                                                          source url
                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                          spl effective date
                                                                                          2026-01-21
                                                                                          spl set id
                                                                                          823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                          spl version
                                                                                          22
                                                                                          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
                                                                                          2999
                                                                                          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
                                                                                          267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                          offset unit
                                                                                          unicode_code_points
                                                                                          source array index
                                                                                          0
                                                                                          source field
                                                                                          indications_and_usage_exact
                                                                                          source text sha256
                                                                                          f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                          start
                                                                                          2597
                                                                                          current approval status
                                                                                          not_reconciled
                                                                                          duplicate text group
                                                                                          dup-73af3fd15cf9e69b042a
                                                                                          extraction review status
                                                                                          automated_candidate_pending_source_review
                                                                                          generic names
                                                                                          1. METHYLPREDNISOLONE ACETATE
                                                                                          id
                                                                                          ind-span-7afa19334174e68d4fff
                                                                                          label id
                                                                                          267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                          positive predicate support span
                                                                                          Source null
                                                                                          qualifier mentions
                                                                                            regulatory links
                                                                                              schema version
                                                                                              0.1.0
                                                                                              source batch sha256
                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                              source defined aliases
                                                                                                source span
                                                                                                end
                                                                                                2799
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                B.
                                                                                                label id
                                                                                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                start
                                                                                                2797
                                                                                                source url
                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                                spl effective date
                                                                                                2026-01-21
                                                                                                spl set id
                                                                                                823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                                spl version
                                                                                                22
                                                                                                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
                                                                                                3356
                                                                                                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
                                                                                                label id
                                                                                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                start
                                                                                                2600
                                                                                                current approval status
                                                                                                not_reconciled
                                                                                                duplicate text group
                                                                                                dup-8f35afd132fa704ae129
                                                                                                extraction review status
                                                                                                automated_candidate_pending_source_review
                                                                                                generic names
                                                                                                1. METHYLPREDNISOLONE ACETATE
                                                                                                id
                                                                                                ind-span-98e7f17967acc0e92533
                                                                                                label id
                                                                                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                positive predicate support span
                                                                                                end
                                                                                                2890
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                is indicated
                                                                                                label id
                                                                                                267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                start
                                                                                                2878
                                                                                                qualifier mentions
                                                                                                  regulatory links
                                                                                                    schema version
                                                                                                    0.1.0
                                                                                                    source batch sha256
                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                    source defined aliases
                                                                                                      source span
                                                                                                      end
                                                                                                      3156
                                                                                                      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
                                                                                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                      offset unit
                                                                                                      unicode_code_points
                                                                                                      source array index
                                                                                                      0
                                                                                                      source field
                                                                                                      indications_and_usage_exact
                                                                                                      source text sha256
                                                                                                      f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                      start
                                                                                                      2800
                                                                                                      source url
                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                                      spl effective date
                                                                                                      2026-01-21
                                                                                                      spl set id
                                                                                                      823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                                      spl version
                                                                                                      22
                                                                                                      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
                                                                                                      3359
                                                                                                      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
                                                                                                      label id
                                                                                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                      offset unit
                                                                                                      unicode_code_points
                                                                                                      source array index
                                                                                                      0
                                                                                                      source field
                                                                                                      indications_and_usage_exact
                                                                                                      source text sha256
                                                                                                      f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                      start
                                                                                                      2957
                                                                                                      current approval status
                                                                                                      not_reconciled
                                                                                                      duplicate text group
                                                                                                      dup-6562635dad0834972017
                                                                                                      extraction review status
                                                                                                      automated_candidate_pending_source_review
                                                                                                      generic names
                                                                                                      1. METHYLPREDNISOLONE ACETATE
                                                                                                      id
                                                                                                      ind-span-e82744455fb481af79a3
                                                                                                      label id
                                                                                                      267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                      positive predicate support span
                                                                                                      Source null
                                                                                                      qualifier mentions
                                                                                                        regulatory links
                                                                                                          schema version
                                                                                                          0.1.0
                                                                                                          source batch sha256
                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                          source defined aliases
                                                                                                            source span
                                                                                                            end
                                                                                                            3159
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            C.
                                                                                                            label id
                                                                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                            start
                                                                                                            3157
                                                                                                            source url
                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                                            spl effective date
                                                                                                            2026-01-21
                                                                                                            spl set id
                                                                                                            823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                                            spl version
                                                                                                            22
                                                                                                            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
                                                                                                            3583
                                                                                                            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
                                                                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                            start
                                                                                                            2960
                                                                                                            current approval status
                                                                                                            not_reconciled
                                                                                                            duplicate text group
                                                                                                            dup-7382127a3d4daa1d83ea
                                                                                                            extraction review status
                                                                                                            automated_candidate_pending_source_review
                                                                                                            generic names
                                                                                                            1. METHYLPREDNISOLONE ACETATE
                                                                                                            id
                                                                                                            ind-span-53e9b14906694d0748a4
                                                                                                            label id
                                                                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                            positive predicate support span
                                                                                                            end
                                                                                                            3217
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            is indicated
                                                                                                            label id
                                                                                                            267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                            start
                                                                                                            3205
                                                                                                            qualifier mentions
                                                                                                              regulatory links
                                                                                                                schema version
                                                                                                                0.1.0
                                                                                                                source batch sha256
                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                source defined aliases
                                                                                                                  source span
                                                                                                                  end
                                                                                                                  3496
                                                                                                                  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
                                                                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                                  start
                                                                                                                  3160
                                                                                                                  source url
                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                                                  spl effective date
                                                                                                                  2026-01-21
                                                                                                                  spl set id
                                                                                                                  823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                                                  spl version
                                                                                                                  22
                                                                                                                  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
                                                                                                                  3583
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  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
                                                                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                                  start
                                                                                                                  3297
                                                                                                                  current approval status
                                                                                                                  not_reconciled
                                                                                                                  duplicate text group
                                                                                                                  dup-64f3c77d92e9ab747392
                                                                                                                  extraction review status
                                                                                                                  automated_candidate_pending_source_review
                                                                                                                  generic names
                                                                                                                  1. METHYLPREDNISOLONE ACETATE
                                                                                                                  id
                                                                                                                  ind-span-9fd28f199dde6311a174
                                                                                                                  label id
                                                                                                                  267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                                  positive predicate support span
                                                                                                                  Source null
                                                                                                                  qualifier mentions
                                                                                                                    regulatory links
                                                                                                                      schema version
                                                                                                                      0.1.0
                                                                                                                      source batch sha256
                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                      source defined aliases
                                                                                                                        source span
                                                                                                                        end
                                                                                                                        3583
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                                        label id
                                                                                                                        267dd735-f800-4735-ba1c-d39d00f0cee5
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        f362048a9e628765a78f440a89afe5157b153948a053e7c53354da25c16830d1
                                                                                                                        start
                                                                                                                        3497
                                                                                                                        source url
                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22267dd735-f800-4735-ba1c-d39d00f0cee5%22
                                                                                                                        spl effective date
                                                                                                                        2026-01-21
                                                                                                                        spl set id
                                                                                                                        823b0010-2b57-4e76-b5ac-4a8c2963438f
                                                                                                                        spl version
                                                                                                                        22
                                                                                                                        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