Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 502f3a8b-e971-c921-e063-6294a90ae933

CELESTONE SOLUSPAN

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
2026-04-24
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic 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. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension 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. The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for 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. CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Full extracted label fields
application numbers
  1. NDA014602
boxed warning exact
    brand names
    1. CELESTONE SOLUSPAN
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=95a19c2f-c329-4ce1-a0a7-174814aac3ad
    generic names
    1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
    id
    502f3a8b-e971-c921-e063-6294a90ae933
    indications and usage exact
    1. INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic 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. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension 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. The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for 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. CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
    indications and usage tables exact
      is original packager
        manufacturer names
        1. Sportpharm LLC
        matched search terms
        1. cancer
        2. lymphomas
        3. tumor
        4. tumors
        package ndcs
        1. 85766-070-05
        product ndcs
        1. 85766-070
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. INTRA-ARTICULAR
          2. INTRALESIONAL
          3. INTRAMUSCULAR
          4. SOFT TISSUE
          rxcuis
          1. 578803
          2. 578806
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00300.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
          300
          total
          830
          sha256
          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
          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=300&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
          spl effective date
          2026-04-24
          spl effective time
          20260424
          spl set id
          95a19c2f-c329-4ce1-a0a7-174814aac3ad
          spl version
          2
          substance names
          1. BETAMETHASONE ACETATE
          2. BETAMETHASONE SODIUM PHOSPHATE
          uniis
          1. TI05AO53L7
          2. 7BK02SCL3W
          verification flags
          1. oncology_keyword_candidate_not_clinically_classified
          2. spl_text_not_verified_identical_to_latest_approved_label
          3. individual_indications_not_split_or_reconciled
          4. not_identified_as_original_packager
          Drugs@FDA application source records
          1. application number
            NDA014602
            payload
            all indexed label documents
            1. Appl No
              014602
              Application Docs Date
              2015-02-05 00:00:00
              Application Docs ID
              10844
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              59
              Submission Type
              SUPPL
            2. Appl No
              014602
              Application Docs Date
              2008-06-26 00:00:00
              Application Docs ID
              33122
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              47
              Submission Type
              SUPPL
            3. Appl No
              014602
              Application Docs Date
              2014-07-08 00:00:00
              Application Docs ID
              33123
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              58
              Submission Type
              SUPPL
            4. Appl No
              014602
              Application Docs Date
              2018-02-12 00:00:00
              Application Docs ID
              52562
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              61
              Submission Type
              SUPPL
            5. Appl No
              014602
              Application Docs Date
              2018-04-11 00:00:00
              Application Docs ID
              53651
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              62
              Submission Type
              SUPPL
            6. Appl No
              014602
              Application Docs Date
              2022-09-10 00:00:00
              Application Docs ID
              72062
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              65
              Submission Type
              SUPPL
            7. Appl No
              014602
              Application Docs Date
              2024-06-06 00:00:00
              Application Docs ID
              78679
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              68
              Submission Type
              SUPPL
            8. Appl No
              014602
              Application Docs Date
              2024-07-09 00:00:00
              Application Docs ID
              79030
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              64
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              68
              Submission Status
              AP
              Submission Status Date
              2024-06-05 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              65
              Submission Status
              AP
              Submission Status Date
              2022-09-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              64
              Submission Status
              AP
              Submission Status Date
              2024-07-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              62
              Submission Status
              AP
              Submission Status Date
              2018-04-10 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              61
              Submission Status
              AP
              Submission Status Date
              2018-02-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              59
              Submission Status
              AP
              Submission Status Date
              2015-02-04 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              58
              Submission Status
              AP
              Submission Status Date
              2014-07-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              57
              Submission Status
              AP
              Submission Status Date
              2014-05-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              56
              Submission Status
              AP
              Submission Status Date
              2013-03-13 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              55
              Submission Status
              AP
              Submission Status Date
              2013-01-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              47
              Submission Status
              AP
              Submission Status Date
              2008-06-24 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              014602
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              25
              Submission Status
              AP
              Submission Status Date
              2001-07-24 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA014602
            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
            2024-07-08
            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
              014602
              Application Docs Date
              2024-07-09 00:00:00
              Application Docs ID
              79030
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              64
              Submission Type
              SUPPL
            official application record
            Appl No
            014602
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            ORGANON
            openfda application present
            true
            products
            1. Active Ingredient
              BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
              Appl No
              014602
              Drug Name
              CELESTONE SOLUSPAN
              Form
              INJECTABLE;INJECTION
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              3MG/ML;EQ 3MG BASE/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 · indication intro context
          application numbers
          1. NDA014602
          brand names
          1. CELESTONE SOLUSPAN
          classification reasons
          1. explicit_positive_indication_predicate
          2. no_tumor_directed_keyword_in_positive_statement
          3. incomplete_colon_led_indication_intro
          clinical review status
          pending
          content role
          indication_intro_context
          context span
          end
          643
          end exclusive
          true
          exact text
          INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital a
          label id
          502f3a8b-e971-c921-e063-6294a90ae933
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-3cce14340d10c5198fc8
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
          id
          ind-span-4259fa5e835830e5b51b
          label id
          502f3a8b-e971-c921-e063-6294a90ae933
          positive predicate support span
          end
          139
          end exclusive
          true
          exact text
          is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable Suspension is indicated
          label id
          502f3a8b-e971-c921-e063-6294a90ae933
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
          start
          40
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
              source defined aliases
                source span
                end
                443
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of CELESTONE ® SOLUSPAN ® Injectable 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
                label id
                502f3a8b-e971-c921-e063-6294a90ae933
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                spl effective date
                2026-04-24
                spl set id
                95a19c2f-c329-4ce1-a0a7-174814aac3ad
                spl version
                2
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                not_applicable
                Passage 2 · unclassified context
                application numbers
                1. NDA014602
                brand names
                1. CELESTONE SOLUSPAN
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                810
                end exclusive
                true
                exact text
                ate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenoc
                label id
                502f3a8b-e971-c921-e063-6294a90ae933
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                start
                244
                current approval status
                not_reconciled
                duplicate text group
                dup-74aeb3f88351ddc1e5be
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                id
                ind-span-2e88a3caf46a6dc053cc
                label id
                502f3a8b-e971-c921-e063-6294a90ae933
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                    source defined aliases
                      source span
                      end
                      610
                      end exclusive
                      true
                      exact text
                      Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
                      label id
                      502f3a8b-e971-c921-e063-6294a90ae933
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                      start
                      444
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                      spl effective date
                      2026-04-24
                      spl set id
                      95a19c2f-c329-4ce1-a0a7-174814aac3ad
                      spl version
                      2
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      unclear
                      Passage 3 · unclassified context
                      application numbers
                      1. NDA014602
                      brand names
                      1. CELESTONE SOLUSPAN
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      928
                      end exclusive
                      true
                      exact text
                      sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infan
                      label id
                      502f3a8b-e971-c921-e063-6294a90ae933
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                      start
                      411
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-16cc9d758167bbba869d
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                      id
                      ind-span-76406bca8b82bddf3ffd
                      label id
                      502f3a8b-e971-c921-e063-6294a90ae933
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                          source defined aliases
                            source span
                            end
                            728
                            end exclusive
                            true
                            exact text
                            Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
                            label id
                            502f3a8b-e971-c921-e063-6294a90ae933
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                            start
                            611
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                            spl effective date
                            2026-04-24
                            spl set id
                            95a19c2f-c329-4ce1-a0a7-174814aac3ad
                            spl version
                            2
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            unclear
                            Passage 4 · unclassified context
                            application numbers
                            1. NDA014602
                            brand names
                            1. CELESTONE SOLUSPAN
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            1032
                            end exclusive
                            true
                            exact text
                            osis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the
                            label id
                            502f3a8b-e971-c921-e063-6294a90ae933
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                            start
                            529
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-b77c494b2c37b26e322a
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                            id
                            ind-span-bde9c956f4bc6e723e66
                            label id
                            502f3a8b-e971-c921-e063-6294a90ae933
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                source defined aliases
                                  source span
                                  end
                                  832
                                  end exclusive
                                  true
                                  exact text
                                  Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.
                                  label id
                                  502f3a8b-e971-c921-e063-6294a90ae933
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                  start
                                  729
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                  spl effective date
                                  2026-04-24
                                  spl set id
                                  95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                  spl version
                                  2
                                  structured fields status
                                  not_extracted_no_values_inferred_from_mentions
                                  structured indication
                                  age
                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  unclear
                                  Passage 5 · unclassified context
                                  application numbers
                                  1. NDA014602
                                  brand names
                                  1. CELESTONE SOLUSPAN
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  1193
                                  end exclusive
                                  true
                                  exact text
                                  ngenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond
                                  label id
                                  502f3a8b-e971-c921-e063-6294a90ae933
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                  start
                                  633
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-a301021978a8e9794043
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                  id
                                  ind-span-e7aaefb8db4da89ef976
                                  label id
                                  502f3a8b-e971-c921-e063-6294a90ae933
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                      source defined aliases
                                        source span
                                        end
                                        993
                                        end exclusive
                                        true
                                        exact text
                                        Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance.
                                        label id
                                        502f3a8b-e971-c921-e063-6294a90ae933
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                        start
                                        833
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                        spl effective date
                                        2026-04-24
                                        spl set id
                                        95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                        spl version
                                        2
                                        structured fields status
                                        not_extracted_no_values_inferred_from_mentions
                                        structured indication
                                        age
                                        Source null
                                        approval pathway
                                        Source null
                                        biomarker and test
                                        Source null
                                        disease stage
                                        Source null
                                        limitations
                                        Source null
                                        line
                                        Source null
                                        prior therapy
                                        Source null
                                        regimen
                                        Source null
                                        tumor histology
                                        Source null
                                        use intent
                                        unclear
                                        Passage 6 · unclassified context
                                        application numbers
                                        1. NDA014602
                                        brand names
                                        1. CELESTONE SOLUSPAN
                                        classification reasons
                                        1. no_unambiguous_positive_indication_predicate
                                        clinical review status
                                        pending
                                        content role
                                        unclassified_context
                                        context span
                                        end
                                        1323
                                        end exclusive
                                        true
                                        exact text
                                        econdary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic o
                                        label id
                                        502f3a8b-e971-c921-e063-6294a90ae933
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                        start
                                        794
                                        current approval status
                                        not_reconciled
                                        duplicate text group
                                        dup-623c7d24cbd13f724e3e
                                        extraction review status
                                        automated_candidate_pending_source_review
                                        generic names
                                        1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                        id
                                        ind-span-1bcada85340ffb7849c9
                                        label id
                                        502f3a8b-e971-c921-e063-6294a90ae933
                                        positive predicate support span
                                        Source null
                                        qualifier mentions
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                            source defined aliases
                                              source span
                                              end
                                              1123
                                              end exclusive
                                              true
                                              exact text
                                              Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
                                              label id
                                              502f3a8b-e971-c921-e063-6294a90ae933
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                              start
                                              994
                                              source url
                                              https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                              spl effective date
                                              2026-04-24
                                              spl set id
                                              95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                              spl version
                                              2
                                              structured fields status
                                              not_extracted_no_values_inferred_from_mentions
                                              structured indication
                                              age
                                              Source null
                                              approval pathway
                                              Source null
                                              biomarker and test
                                              Source null
                                              disease stage
                                              Source null
                                              limitations
                                              Source null
                                              line
                                              Source null
                                              prior therapy
                                              Source null
                                              regimen
                                              Source null
                                              tumor histology
                                              Source null
                                              use intent
                                              unclear
                                              Passage 7 · unclassified context
                                              application numbers
                                              1. NDA014602
                                              brand names
                                              1. CELESTONE SOLUSPAN
                                              classification reasons
                                              1. no_unambiguous_positive_indication_predicate
                                              clinical review status
                                              pending
                                              content role
                                              unclassified_context
                                              context span
                                              end
                                              1479
                                              end exclusive
                                              true
                                              exact text
                                              nfancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplas
                                              label id
                                              502f3a8b-e971-c921-e063-6294a90ae933
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                              start
                                              924
                                              current approval status
                                              not_reconciled
                                              duplicate text group
                                              dup-5c5e7e8b33009055c15d
                                              extraction review status
                                              automated_candidate_pending_source_review
                                              generic names
                                              1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                              id
                                              ind-span-3d9bf48afda8d9e32737
                                              label id
                                              502f3a8b-e971-c921-e063-6294a90ae933
                                              positive predicate support span
                                              Source null
                                              qualifier mentions
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                  source defined aliases
                                                    source span
                                                    end
                                                    1279
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
                                                    label id
                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                    start
                                                    1124
                                                    source url
                                                    https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                    spl effective date
                                                    2026-04-24
                                                    spl set id
                                                    95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                    spl version
                                                    2
                                                    structured fields status
                                                    not_extracted_no_values_inferred_from_mentions
                                                    structured indication
                                                    age
                                                    Source null
                                                    approval pathway
                                                    Source null
                                                    biomarker and test
                                                    Source null
                                                    disease stage
                                                    Source null
                                                    limitations
                                                    Source null
                                                    line
                                                    Source null
                                                    prior therapy
                                                    Source null
                                                    regimen
                                                    Source null
                                                    tumor histology
                                                    Source null
                                                    use intent
                                                    unclear
                                                    Passage 8 · unclassified context
                                                    application numbers
                                                    1. NDA014602
                                                    brand names
                                                    1. CELESTONE SOLUSPAN
                                                    classification reasons
                                                    1. no_unambiguous_positive_indication_predicate
                                                    clinical review status
                                                    pending
                                                    content role
                                                    unclassified_context
                                                    context span
                                                    end
                                                    1671
                                                    end exclusive
                                                    true
                                                    exact text
                                                    regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or
                                                    label id
                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                    start
                                                    1080
                                                    current approval status
                                                    not_reconciled
                                                    duplicate text group
                                                    dup-7f6dca16f2c617e1d398
                                                    extraction review status
                                                    automated_candidate_pending_source_review
                                                    generic names
                                                    1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                    id
                                                    ind-span-7aecd1ea2f86b34dea25
                                                    label id
                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                    positive predicate support span
                                                    Source null
                                                    qualifier mentions
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
                                                        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                        source defined aliases
                                                          source span
                                                          end
                                                          1471
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
                                                          label id
                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                          start
                                                          1280
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                          spl effective date
                                                          2026-04-24
                                                          spl set id
                                                          95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                          spl version
                                                          2
                                                          structured fields status
                                                          not_extracted_no_values_inferred_from_mentions
                                                          structured indication
                                                          age
                                                          Source null
                                                          approval pathway
                                                          Source null
                                                          biomarker and test
                                                          Source null
                                                          disease stage
                                                          Source null
                                                          limitations
                                                          Source null
                                                          line
                                                          Source null
                                                          prior therapy
                                                          Source null
                                                          regimen
                                                          Source null
                                                          tumor histology
                                                          Source null
                                                          use intent
                                                          unclear
                                                          Passage 9 · unclassified context
                                                          application numbers
                                                          1. NDA014602
                                                          brand names
                                                          1. CELESTONE SOLUSPAN
                                                          classification reasons
                                                          1. no_unambiguous_positive_indication_predicate
                                                          clinical review status
                                                          pending
                                                          content role
                                                          unclassified_context
                                                          context span
                                                          end
                                                          1745
                                                          end exclusive
                                                          true
                                                          exact text
                                                          openia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteriti
                                                          label id
                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                          start
                                                          1272
                                                          current approval status
                                                          not_reconciled
                                                          duplicate text group
                                                          dup-303c425d15c6c38b6912
                                                          extraction review status
                                                          automated_candidate_pending_source_review
                                                          generic names
                                                          1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                          id
                                                          ind-span-9eabdcd4c194ffafed77
                                                          label id
                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                          positive predicate support span
                                                          Source null
                                                          qualifier mentions
                                                            regulatory links
                                                              schema version
                                                              0.1.0
                                                              source batch sha256
                                                              bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                              source defined aliases
                                                                source span
                                                                end
                                                                1545
                                                                end exclusive
                                                                true
                                                                exact text
                                                                Neoplastic Diseases For palliative management of leukemias and lymphomas.
                                                                label id
                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                start
                                                                1472
                                                                source url
                                                                https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                spl effective date
                                                                2026-04-24
                                                                spl set id
                                                                95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                spl version
                                                                2
                                                                structured fields status
                                                                not_extracted_no_values_inferred_from_mentions
                                                                structured indication
                                                                age
                                                                Source null
                                                                approval pathway
                                                                Source null
                                                                biomarker and test
                                                                Source null
                                                                disease stage
                                                                Source null
                                                                limitations
                                                                Source null
                                                                line
                                                                Source null
                                                                prior therapy
                                                                Source null
                                                                regimen
                                                                Source null
                                                                tumor histology
                                                                Source null
                                                                use intent
                                                                unclear
                                                                Passage 10 · unclassified context
                                                                application numbers
                                                                1. NDA014602
                                                                brand names
                                                                1. CELESTONE SOLUSPAN
                                                                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
                                                                t, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases To induce diuresis or remission of p
                                                                label id
                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                start
                                                                1346
                                                                current approval status
                                                                not_reconciled
                                                                duplicate text group
                                                                dup-2bafc9b6425d183bd79d
                                                                extraction review status
                                                                automated_candidate_pending_source_review
                                                                generic names
                                                                1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                id
                                                                ind-span-c60e1744d95e3cde2b08
                                                                label id
                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                positive predicate support span
                                                                Source null
                                                                qualifier mentions
                                                                1. context exact
                                                                  ltiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                                  kind
                                                                  biomarker
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  1682
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  metastatic brain tumor or craniotomy
                                                                  label id
                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                  start
                                                                  1646
                                                                2. context exact
                                                                  ltiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                                  kind
                                                                  stage_or_setting
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  1682
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  metastatic brain tumor or craniotomy
                                                                  label id
                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                  start
                                                                  1646
                                                                regulatory links
                                                                  schema version
                                                                  0.1.0
                                                                  source batch sha256
                                                                  bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                  source defined aliases
                                                                    source span
                                                                    end
                                                                    1683
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
                                                                    label id
                                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                    start
                                                                    1546
                                                                    source url
                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                    spl effective date
                                                                    2026-04-24
                                                                    spl set id
                                                                    95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                    spl version
                                                                    2
                                                                    structured fields status
                                                                    not_extracted_no_values_inferred_from_mentions
                                                                    structured indication
                                                                    age
                                                                    Source null
                                                                    approval pathway
                                                                    Source null
                                                                    biomarker and test
                                                                    Source null
                                                                    disease stage
                                                                    Source null
                                                                    limitations
                                                                    Source null
                                                                    line
                                                                    Source null
                                                                    prior therapy
                                                                    Source null
                                                                    regimen
                                                                    Source null
                                                                    tumor histology
                                                                    Source null
                                                                    use intent
                                                                    unclear
                                                                    Passage 11 · unclassified context
                                                                    application numbers
                                                                    1. NDA014602
                                                                    brand names
                                                                    1. CELESTONE SOLUSPAN
                                                                    classification reasons
                                                                    1. no_unambiguous_positive_indication_predicate
                                                                    clinical review status
                                                                    pending
                                                                    content role
                                                                    unclassified_context
                                                                    context span
                                                                    end
                                                                    2031
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    iseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic 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 pulmon
                                                                    label id
                                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                    start
                                                                    1484
                                                                    current approval status
                                                                    not_reconciled
                                                                    duplicate text group
                                                                    dup-eb247398233b8a358a89
                                                                    extraction review status
                                                                    automated_candidate_pending_source_review
                                                                    generic names
                                                                    1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                    id
                                                                    ind-span-9ebb4e705705f89a62a4
                                                                    label id
                                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                                    positive predicate support span
                                                                    Source null
                                                                    qualifier mentions
                                                                      regulatory links
                                                                        schema version
                                                                        0.1.0
                                                                        source batch sha256
                                                                        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                        source defined aliases
                                                                          source span
                                                                          end
                                                                          1831
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
                                                                          label id
                                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                          start
                                                                          1684
                                                                          source url
                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                          spl effective date
                                                                          2026-04-24
                                                                          spl set id
                                                                          95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                          spl version
                                                                          2
                                                                          structured fields status
                                                                          not_extracted_no_values_inferred_from_mentions
                                                                          structured indication
                                                                          age
                                                                          Source null
                                                                          approval pathway
                                                                          Source null
                                                                          biomarker and test
                                                                          Source null
                                                                          disease stage
                                                                          Source null
                                                                          limitations
                                                                          Source null
                                                                          line
                                                                          Source null
                                                                          prior therapy
                                                                          Source null
                                                                          regimen
                                                                          Source null
                                                                          tumor histology
                                                                          Source null
                                                                          use intent
                                                                          unclear
                                                                          Passage 12 · unclassified context
                                                                          application numbers
                                                                          1. NDA014602
                                                                          brand names
                                                                          1. CELESTONE SOLUSPAN
                                                                          classification reasons
                                                                          1. no_unambiguous_positive_indication_predicate
                                                                          clinical review status
                                                                          pending
                                                                          content role
                                                                          unclassified_context
                                                                          context span
                                                                          end
                                                                          2162
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          th 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, symptoma
                                                                          label id
                                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                          start
                                                                          1632
                                                                          current approval status
                                                                          not_reconciled
                                                                          duplicate text group
                                                                          dup-4284b945aba2ad21458e
                                                                          extraction review status
                                                                          automated_candidate_pending_source_review
                                                                          generic names
                                                                          1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                          id
                                                                          ind-span-276909fbfd3a25e6a17b
                                                                          label id
                                                                          502f3a8b-e971-c921-e063-6294a90ae933
                                                                          positive predicate support span
                                                                          Source null
                                                                          qualifier mentions
                                                                            regulatory links
                                                                              schema version
                                                                              0.1.0
                                                                              source batch sha256
                                                                              bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                              source defined aliases
                                                                                source span
                                                                                end
                                                                                1962
                                                                                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
                                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                start
                                                                                1832
                                                                                source url
                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                spl effective date
                                                                                2026-04-24
                                                                                spl set id
                                                                                95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                spl version
                                                                                2
                                                                                structured fields status
                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                structured indication
                                                                                age
                                                                                Source null
                                                                                approval pathway
                                                                                Source null
                                                                                biomarker and test
                                                                                Source null
                                                                                disease stage
                                                                                Source null
                                                                                limitations
                                                                                Source null
                                                                                line
                                                                                Source null
                                                                                prior therapy
                                                                                Source null
                                                                                regimen
                                                                                Source null
                                                                                tumor histology
                                                                                Source null
                                                                                use intent
                                                                                unclear
                                                                                Passage 13 · unclassified context
                                                                                application numbers
                                                                                1. NDA014602
                                                                                brand names
                                                                                1. CELESTONE SOLUSPAN
                                                                                classification reasons
                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                clinical review status
                                                                                pending
                                                                                content role
                                                                                unclassified_context
                                                                                context span
                                                                                end
                                                                                2378
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                lar 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 spon
                                                                                label id
                                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                start
                                                                                1763
                                                                                current approval status
                                                                                not_reconciled
                                                                                duplicate text group
                                                                                dup-7fc30725952d26901c0a
                                                                                extraction review status
                                                                                automated_candidate_pending_source_review
                                                                                generic names
                                                                                1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                id
                                                                                ind-span-7a2a81aa7ad74ab119c1
                                                                                label id
                                                                                502f3a8b-e971-c921-e063-6294a90ae933
                                                                                positive predicate support span
                                                                                Source null
                                                                                qualifier mentions
                                                                                  regulatory links
                                                                                    schema version
                                                                                    0.1.0
                                                                                    source batch sha256
                                                                                    bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                    source defined aliases
                                                                                      source span
                                                                                      end
                                                                                      2178
                                                                                      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
                                                                                      502f3a8b-e971-c921-e063-6294a90ae933
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                      start
                                                                                      1963
                                                                                      source url
                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                      spl effective date
                                                                                      2026-04-24
                                                                                      spl set id
                                                                                      95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                      spl version
                                                                                      2
                                                                                      structured fields status
                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                      structured indication
                                                                                      age
                                                                                      Source null
                                                                                      approval pathway
                                                                                      Source null
                                                                                      biomarker and test
                                                                                      Source null
                                                                                      disease stage
                                                                                      Source null
                                                                                      limitations
                                                                                      Source null
                                                                                      line
                                                                                      Source null
                                                                                      prior therapy
                                                                                      Source null
                                                                                      regimen
                                                                                      Source null
                                                                                      tumor histology
                                                                                      Source null
                                                                                      use intent
                                                                                      unclear
                                                                                      Passage 14 · unclassified context
                                                                                      application numbers
                                                                                      1. NDA014602
                                                                                      brand names
                                                                                      1. CELESTONE SOLUSPAN
                                                                                      classification reasons
                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                      clinical review status
                                                                                      pending
                                                                                      content role
                                                                                      unclassified_context
                                                                                      context span
                                                                                      end
                                                                                      2728
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      ases 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. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension is indicated as adj
                                                                                      label id
                                                                                      502f3a8b-e971-c921-e063-6294a90ae933
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                      start
                                                                                      1979
                                                                                      current approval status
                                                                                      not_reconciled
                                                                                      duplicate text group
                                                                                      dup-9b8cfaee2c4ac51d800d
                                                                                      extraction review status
                                                                                      automated_candidate_pending_source_review
                                                                                      generic names
                                                                                      1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                      id
                                                                                      ind-span-0ef5bf86aebaf1e86faf
                                                                                      label id
                                                                                      502f3a8b-e971-c921-e063-6294a90ae933
                                                                                      positive predicate support span
                                                                                      Source null
                                                                                      qualifier mentions
                                                                                        regulatory links
                                                                                          schema version
                                                                                          0.1.0
                                                                                          source batch sha256
                                                                                          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                          source defined aliases
                                                                                            source span
                                                                                            end
                                                                                            2528
                                                                                            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
                                                                                            502f3a8b-e971-c921-e063-6294a90ae933
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                            start
                                                                                            2179
                                                                                            source url
                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                            spl effective date
                                                                                            2026-04-24
                                                                                            spl set id
                                                                                            95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                            spl version
                                                                                            2
                                                                                            structured fields status
                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                            structured indication
                                                                                            age
                                                                                            Source null
                                                                                            approval pathway
                                                                                            Source null
                                                                                            biomarker and test
                                                                                            Source null
                                                                                            disease stage
                                                                                            Source null
                                                                                            limitations
                                                                                            Source null
                                                                                            line
                                                                                            Source null
                                                                                            prior therapy
                                                                                            Source null
                                                                                            regimen
                                                                                            Source null
                                                                                            tumor histology
                                                                                            Source null
                                                                                            use intent
                                                                                            unclear
                                                                                            Passage 15 · unclassified context
                                                                                            application numbers
                                                                                            1. NDA014602
                                                                                            brand names
                                                                                            1. CELESTONE SOLUSPAN
                                                                                            classification reasons
                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                            clinical review status
                                                                                            pending
                                                                                            content role
                                                                                            unclassified_context
                                                                                            context span
                                                                                            end
                                                                                            2814
                                                                                            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. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episo
                                                                                            label id
                                                                                            502f3a8b-e971-c921-e063-6294a90ae933
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                            start
                                                                                            2329
                                                                                            current approval status
                                                                                            not_reconciled
                                                                                            duplicate text group
                                                                                            dup-997514b22782a6a227dc
                                                                                            extraction review status
                                                                                            automated_candidate_pending_source_review
                                                                                            generic names
                                                                                            1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                            id
                                                                                            ind-span-60736d0932c052704f3c
                                                                                            label id
                                                                                            502f3a8b-e971-c921-e063-6294a90ae933
                                                                                            positive predicate support span
                                                                                            Source null
                                                                                            qualifier mentions
                                                                                              regulatory links
                                                                                                schema version
                                                                                                0.1.0
                                                                                                source batch sha256
                                                                                                bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                                source defined aliases
                                                                                                  source span
                                                                                                  end
                                                                                                  2614
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
                                                                                                  label id
                                                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                  start
                                                                                                  2529
                                                                                                  source url
                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                                  spl effective date
                                                                                                  2026-04-24
                                                                                                  spl set id
                                                                                                  95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                                  spl version
                                                                                                  2
                                                                                                  structured fields status
                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                  structured indication
                                                                                                  age
                                                                                                  Source null
                                                                                                  approval pathway
                                                                                                  Source null
                                                                                                  biomarker and test
                                                                                                  Source null
                                                                                                  disease stage
                                                                                                  Source null
                                                                                                  limitations
                                                                                                  Source null
                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
                                                                                                  Source null
                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  unclear
                                                                                                  Passage 16 · positive indication candidate
                                                                                                  application numbers
                                                                                                  1. NDA014602
                                                                                                  brand names
                                                                                                  1. CELESTONE SOLUSPAN
                                                                                                  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
                                                                                                  3187
                                                                                                  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. The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension 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. The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory
                                                                                                  label id
                                                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                  start
                                                                                                  2415
                                                                                                  current approval status
                                                                                                  not_reconciled
                                                                                                  duplicate text group
                                                                                                  dup-0ba6c5b09c9929dc0c28
                                                                                                  extraction review status
                                                                                                  automated_candidate_pending_source_review
                                                                                                  generic names
                                                                                                  1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                                  id
                                                                                                  ind-span-727829a15ef9bd27a962
                                                                                                  label id
                                                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                  positive predicate support span
                                                                                                  end
                                                                                                  2721
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  is indicated
                                                                                                  label id
                                                                                                  502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                  start
                                                                                                  2709
                                                                                                  qualifier mentions
                                                                                                    regulatory links
                                                                                                      schema version
                                                                                                      0.1.0
                                                                                                      source batch sha256
                                                                                                      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                                      source defined aliases
                                                                                                        source span
                                                                                                        end
                                                                                                        2987
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension 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
                                                                                                        502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                        start
                                                                                                        2615
                                                                                                        source url
                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                                        spl effective date
                                                                                                        2026-04-24
                                                                                                        spl set id
                                                                                                        95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                                        spl version
                                                                                                        2
                                                                                                        structured fields status
                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                        structured indication
                                                                                                        age
                                                                                                        Source null
                                                                                                        approval pathway
                                                                                                        Source null
                                                                                                        biomarker and test
                                                                                                        Source null
                                                                                                        disease stage
                                                                                                        Source null
                                                                                                        limitations
                                                                                                        Source null
                                                                                                        line
                                                                                                        Source null
                                                                                                        prior therapy
                                                                                                        Source null
                                                                                                        regimen
                                                                                                        Source null
                                                                                                        tumor histology
                                                                                                        Source null
                                                                                                        use intent
                                                                                                        non_oncology_or_unclear_candidate
                                                                                                        Passage 17 · positive indication candidate
                                                                                                        application numbers
                                                                                                        1. NDA014602
                                                                                                        brand names
                                                                                                        1. CELESTONE SOLUSPAN
                                                                                                        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
                                                                                                        3451
                                                                                                        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. The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for 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. CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                        label id
                                                                                                        502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                        start
                                                                                                        2788
                                                                                                        current approval status
                                                                                                        not_reconciled
                                                                                                        duplicate text group
                                                                                                        dup-7ff13ad1f3c33fc44af0
                                                                                                        extraction review status
                                                                                                        automated_candidate_pending_source_review
                                                                                                        generic names
                                                                                                        1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                                        id
                                                                                                        ind-span-20305e43c922517fa44c
                                                                                                        label id
                                                                                                        502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                        positive predicate support span
                                                                                                        end
                                                                                                        3077
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        is indicated
                                                                                                        label id
                                                                                                        502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                        start
                                                                                                        3065
                                                                                                        qualifier mentions
                                                                                                          regulatory links
                                                                                                            schema version
                                                                                                            0.1.0
                                                                                                            source batch sha256
                                                                                                            bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                                            source defined aliases
                                                                                                              source span
                                                                                                              end
                                                                                                              3335
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for 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
                                                                                                              502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                              start
                                                                                                              2988
                                                                                                              source url
                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                                              spl effective date
                                                                                                              2026-04-24
                                                                                                              spl set id
                                                                                                              95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                                              spl version
                                                                                                              2
                                                                                                              structured fields status
                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                              structured indication
                                                                                                              age
                                                                                                              Source null
                                                                                                              approval pathway
                                                                                                              Source null
                                                                                                              biomarker and test
                                                                                                              Source null
                                                                                                              disease stage
                                                                                                              Source null
                                                                                                              limitations
                                                                                                              Source null
                                                                                                              line
                                                                                                              Source null
                                                                                                              prior therapy
                                                                                                              Source null
                                                                                                              regimen
                                                                                                              Source null
                                                                                                              tumor histology
                                                                                                              Source null
                                                                                                              use intent
                                                                                                              non_oncology_or_unclear_candidate
                                                                                                              Passage 18 · unclassified context
                                                                                                              application numbers
                                                                                                              1. NDA014602
                                                                                                              brand names
                                                                                                              1. CELESTONE SOLUSPAN
                                                                                                              classification reasons
                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                              clinical review status
                                                                                                              pending
                                                                                                              content role
                                                                                                              unclassified_context
                                                                                                              context span
                                                                                                              end
                                                                                                              3451
                                                                                                              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. CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                              label id
                                                                                                              502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                              start
                                                                                                              3136
                                                                                                              current approval status
                                                                                                              not_reconciled
                                                                                                              duplicate text group
                                                                                                              dup-ac4ceccc71ffeda2e5ab
                                                                                                              extraction review status
                                                                                                              automated_candidate_pending_source_review
                                                                                                              generic names
                                                                                                              1. BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
                                                                                                              id
                                                                                                              ind-span-380a6f8d8f966a3795a4
                                                                                                              label id
                                                                                                              502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                              positive predicate support span
                                                                                                              Source null
                                                                                                              qualifier mentions
                                                                                                                regulatory links
                                                                                                                  schema version
                                                                                                                  0.1.0
                                                                                                                  source batch sha256
                                                                                                                  bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                                                                                                  source defined aliases
                                                                                                                    source span
                                                                                                                    end
                                                                                                                    3451
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
                                                                                                                    label id
                                                                                                                    502f3a8b-e971-c921-e063-6294a90ae933
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    435114226b81d7093fc8dbccfbbc0000e7144da7266bf6d4053c4a9038f2209e
                                                                                                                    start
                                                                                                                    3336
                                                                                                                    source url
                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22502f3a8b-e971-c921-e063-6294a90ae933%22
                                                                                                                    spl effective date
                                                                                                                    2026-04-24
                                                                                                                    spl set id
                                                                                                                    95a19c2f-c329-4ce1-a0a7-174814aac3ad
                                                                                                                    spl version
                                                                                                                    2
                                                                                                                    structured fields status
                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                    structured indication
                                                                                                                    age
                                                                                                                    Source null
                                                                                                                    approval pathway
                                                                                                                    Source null
                                                                                                                    biomarker and test
                                                                                                                    Source null
                                                                                                                    disease stage
                                                                                                                    Source null
                                                                                                                    limitations
                                                                                                                    Source null
                                                                                                                    line
                                                                                                                    Source null
                                                                                                                    prior therapy
                                                                                                                    Source null
                                                                                                                    regimen
                                                                                                                    Source null
                                                                                                                    tumor histology
                                                                                                                    Source null
                                                                                                                    use intent
                                                                                                                    unclear

                                                                                                                    Preserved source evidence · Not medical advice