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

LABELS · ebbc1751-9381-4db1-89ff-ae5a2963fb2c

prednisolone sodium phosphate ODT

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
2024-04-18
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS & USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablet is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1) for the treatment of certain endocrine conditions (1) for palliation of certain neoplastic conditions (1) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Hypersensitivity pneumonitis Idiopathic bronchiolitis obliterans with organizing pneumonia Idiopathic eosinophilic pneumonias Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Ankylosing spondylitis Dermatomyositis/polymyositis Polymyalgia rheumatica/temporal arteritis Psoriatic arthritis Relapsing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis 1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituberculous chemotherapy
Full extracted label fields
application numbers
  1. NDA021959
boxed warning exact
    brand names
    1. prednisolone sodium phosphate ODT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebbc1751-9381-4db1-89ff-ae5a2963fb2c
    generic names
    1. PREDNISOLONE SODIUM PHOSPHATE
    id
    ebbc1751-9381-4db1-89ff-ae5a2963fb2c
    indications and usage exact
    1. 1 INDICATIONS & USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablet is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1) for the treatment of certain endocrine conditions (1) for palliation of certain neoplastic conditions (1) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Hypersensitivity pneumonitis Idiopathic bronchiolitis obliterans with organizing pneumonia Idiopathic eosinophilic pneumonias Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Ankylosing spondylitis Dermatomyositis/polymyositis Polymyalgia rheumatica/temporal arteritis Psoriatic arthritis Relapsing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis 1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituberculous chemotherapy
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Ingenus Pharmaceuticals, LLC
      matched search terms
      1. lymphomas
      2. leukemia
      3. tumor
      4. malignancy
      package ndcs
      1. 50742-383-06
      2. 50742-383-12
      3. 50742-384-06
      4. 50742-384-12
      5. 50742-385-06
      6. 50742-385-12
      product ndcs
      1. 50742-383
      2. 50742-384
      3. 50742-385
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Immunosuppression and Increased Risk of Infection (5.2) 3/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 643123
      2. 643125
      3. 643127
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      700
      total
      830
      sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
      spl effective date
      2024-04-18
      spl effective time
      20240418
      spl set id
      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
      spl version
      1
      substance names
      1. PREDNISOLONE SODIUM PHOSPHATE
      uniis
      1. IV021NXA9J
      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. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA021959
        payload
        all indexed label documents
        1. Appl No
          021959
          Application Docs Date
          2009-05-11 00:00:00
          Application Docs ID
          16644
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        2. Appl No
          021959
          Application Docs Date
          2010-07-31 00:00:00
          Application Docs ID
          16645
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          021959
          Application Docs Date
          2006-06-02 00:00:00
          Application Docs ID
          37957
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        4. Appl No
          021959
          Application Docs Date
          2020-03-09 00:00:00
          Application Docs ID
          62088
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        5. Appl No
          021959
          Application Docs Date
          2024-06-06 00:00:00
          Application Docs ID
          78685
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2006-06-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          021959
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2009-04-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2010-07-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2016-04-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2016-07-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2020-03-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021959
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2024-06-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA021959
        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
        2024-06-05
        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
          021959
          Application Docs Date
          2024-06-06 00:00:00
          Application Docs ID
          78685
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        official application record
        Appl No
        021959
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ADVANZ PHARMA
        openfda application present
        true
        products
        1. Active Ingredient
          PREDNISOLONE SODIUM PHOSPHATE
          Appl No
          021959
          Drug Name
          ORAPRED ODT
          Form
          TABLET, ORALLY DISINTEGRATING;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 10MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          PREDNISOLONE SODIUM PHOSPHATE
          Appl No
          021959
          Drug Name
          ORAPRED ODT
          Form
          TABLET, ORALLY DISINTEGRATING;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 15MG BASE
          marketing status
          1. Prescription
        3. Active Ingredient
          PREDNISOLONE SODIUM PHOSPHATE
          Appl No
          021959
          Drug Name
          ORAPRED ODT
          Form
          TABLET, ORALLY DISINTEGRATING;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 30MG BASE
          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 · positive indication candidate
      application numbers
      1. NDA021959
      brand names
      1. prednisolone sodium phosphate ODT
      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
      806
      end exclusive
      true
      exact text
      1 INDICATIONS & USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablet is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1) for the treatment of certain endocrine conditions (1) for palliation of certain neoplastic conditions (1) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Dru
      label id
      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-e5ae28a115c8fd6f2973
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. PREDNISOLONE SODIUM PHOSPHATE
      id
      ind-span-cdf8005936401c78f612
      label id
      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
      positive predicate support span
      end
      95
      end exclusive
      true
      exact text
      are indicated
      label id
      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
      start
      82
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          source defined aliases
            source span
            end
            606
            end exclusive
            true
            exact text
            1 INDICATIONS & USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablet is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1) for the treatment of certain endocrine conditions (1) for palliation of certain neoplastic conditions (1)
            label id
            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
            spl effective date
            2024-04-18
            spl set id
            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
            spl version
            1
            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 2 · unclassified context
            application numbers
            1. NDA021959
            brand names
            1. prednisolone sodium phosphate ODT
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            1089
            end exclusive
            true
            exact text
            tory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1) for the treatment of certain endocrine conditions (1) for palliation of certain neoplastic conditions (1) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine
            label id
            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
            start
            407
            current approval status
            not_reconciled
            duplicate text group
            dup-fe9d124aca37c599f6b8
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. PREDNISOLONE SODIUM PHOSPHATE
            id
            ind-span-e88574dc983c6826d1bf
            label id
            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
            positive predicate support span
            Source null
            qualifier mentions
            1. context exact
              intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hype
              kind
              age
              polarity
              not_inferred
              span
              end
              752
              end exclusive
              true
              exact text
              adult
              label id
              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
              start
              747
            2. context exact
              e to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity r
              kind
              age
              polarity
              not_inferred
              span
              end
              766
              end exclusive
              true
              exact text
              pediatric
              label id
              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
              start
              757
            regulatory links
              schema version
              0.1.0
              source batch sha256
              24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
              source defined aliases
                source span
                end
                889
                end exclusive
                true
                exact text
                1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness
                label id
                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                start
                607
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                spl effective date
                2024-04-18
                spl set id
                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                spl version
                1
                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. NDA021959
                brand names
                1. prednisolone sodium phosphate ODT
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                1274
                end exclusive
                true
                exact text
                ractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the fi
                label id
                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                start
                690
                current approval status
                not_reconciled
                duplicate text group
                dup-672f2b4cd373c0f832ba
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. PREDNISOLONE SODIUM PHOSPHATE
                id
                ind-span-5497e694bdae9db17202
                label id
                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                    source defined aliases
                      source span
                      end
                      1074
                      end exclusive
                      true
                      exact text
                      1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome)
                      label id
                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                      start
                      890
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                      spl effective date
                      2024-04-18
                      spl set id
                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                      spl version
                      1
                      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. NDA021959
                      brand names
                      1. prednisolone sodium phosphate ODT
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      1572
                      end exclusive
                      true
                      exact text
                      Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocy
                      label id
                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                      start
                      875
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-e5488938c4d0da134be6
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. PREDNISOLONE SODIUM PHOSPHATE
                      id
                      ind-span-3db4546f2538250ce8cf
                      label id
                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                          source defined aliases
                            source span
                            end
                            1372
                            end exclusive
                            true
                            exact text
                            1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable.
                            label id
                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                            start
                            1075
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                            spl effective date
                            2024-04-18
                            spl set id
                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                            spl version
                            1
                            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. NDA021959
                            brand names
                            1. prednisolone sodium phosphate ODT
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            1663
                            end exclusive
                            true
                            exact text
                            thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Ne
                            label id
                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                            start
                            1173
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-32a9b77e0b80b1ffc26b
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. PREDNISOLONE SODIUM PHOSPHATE
                            id
                            ind-span-281e7a267019bbaf4f2c
                            label id
                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                source defined aliases
                                  source span
                                  end
                                  1463
                                  end exclusive
                                  true
                                  exact text
                                  1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis
                                  label id
                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                  start
                                  1373
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                  spl effective date
                                  2024-04-18
                                  spl set id
                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                  spl version
                                  1
                                  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. NDA021959
                                  brand names
                                  1. prednisolone sodium phosphate ODT
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  1856
                                  end exclusive
                                  true
                                  exact text
                                  is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or m
                                  label id
                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                  start
                                  1264
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-aa8f6124f341801b4c3f
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. PREDNISOLONE SODIUM PHOSPHATE
                                  id
                                  ind-span-d9b0e14632ad9abc5a62
                                  label id
                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                  1. context exact
                                    mond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults
                                    kind
                                    age
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    1597
                                    end exclusive
                                    true
                                    exact text
                                    adults
                                    label id
                                    ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                    start
                                    1591
                                  2. context exact
                                    adults Pure red cell aplasia Secondary thrombocytopenia in adults
                                    kind
                                    age
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    1656
                                    end exclusive
                                    true
                                    exact text
                                    adults
                                    label id
                                    ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                    start
                                    1650
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                    source defined aliases
                                      source span
                                      end
                                      1656
                                      end exclusive
                                      true
                                      exact text
                                      1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults
                                      label id
                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                      start
                                      1464
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                      spl effective date
                                      2024-04-18
                                      spl set id
                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                      spl version
                                      1
                                      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. NDA021959
                                      brand names
                                      1. prednisolone sodium phosphate ODT
                                      classification reasons
                                      1. no_unambiguous_positive_indication_predicate
                                      clinical review status
                                      pending
                                      content role
                                      unclassified_context
                                      context span
                                      end
                                      1940
                                      end exclusive
                                      true
                                      exact text
                                      olitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathet
                                      label id
                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                      start
                                      1457
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-061d7d1bdc619f43329a
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. PREDNISOLONE SODIUM PHOSPHATE
                                      id
                                      ind-span-9b180bfc3fc5181cd8e4
                                      label id
                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                          source defined aliases
                                            source span
                                            end
                                            1740
                                            end exclusive
                                            true
                                            exact text
                                            1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas
                                            label id
                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                            start
                                            1657
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                            spl effective date
                                            2024-04-18
                                            spl set id
                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                            spl version
                                            1
                                            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. NDA021959
                                            brand names
                                            1. prednisolone sodium phosphate ODT
                                            classification reasons
                                            1. no_unambiguous_positive_indication_predicate
                                            clinical review status
                                            pending
                                            content role
                                            unclassified_context
                                            context span
                                            end
                                            2104
                                            end exclusive
                                            true
                                            exact text
                                            fan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic so
                                            label id
                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                            start
                                            1541
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-c09549f68ec7b13e95ba
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. PREDNISOLONE SODIUM PHOSPHATE
                                            id
                                            ind-span-b04d09bd79d7427586ef
                                            label id
                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                            1. context exact
                                              ultiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
                                              kind
                                              biomarker
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1877
                                              end exclusive
                                              true
                                              exact text
                                              metastatic brain tumor
                                              label id
                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                              start
                                              1855
                                            2. context exact
                                              ultiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
                                              kind
                                              stage_or_setting
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1877
                                              end exclusive
                                              true
                                              exact text
                                              metastatic brain tumor
                                              label id
                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                              start
                                              1855
                                            regulatory links
                                              schema version
                                              0.1.0
                                              source batch sha256
                                              24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                              source defined aliases
                                                source span
                                                end
                                                1904
                                                end exclusive
                                                true
                                                exact text
                                                1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
                                                label id
                                                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                start
                                                1741
                                                source url
                                                https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                spl effective date
                                                2024-04-18
                                                spl set id
                                                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                spl version
                                                1
                                                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. NDA021959
                                                brand names
                                                1. prednisolone sodium phosphate ODT
                                                classification reasons
                                                1. no_unambiguous_positive_indication_predicate
                                                clinical review status
                                                pending
                                                content role
                                                unclassified_context
                                                context span
                                                end
                                                2236
                                                end exclusive
                                                true
                                                exact text
                                                Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulm
                                                label id
                                                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                start
                                                1705
                                                current approval status
                                                not_reconciled
                                                duplicate text group
                                                dup-b9138d12ab3d1d2420dc
                                                extraction review status
                                                automated_candidate_pending_source_review
                                                generic names
                                                1. PREDNISOLONE SODIUM PHOSPHATE
                                                id
                                                ind-span-5baed7f1baac65a1f979
                                                label id
                                                ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                positive predicate support span
                                                Source null
                                                qualifier mentions
                                                  regulatory links
                                                    schema version
                                                    0.1.0
                                                    source batch sha256
                                                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                    source defined aliases
                                                      source span
                                                      end
                                                      2036
                                                      end exclusive
                                                      true
                                                      exact text
                                                      1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
                                                      label id
                                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                      start
                                                      1905
                                                      source url
                                                      https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                      spl effective date
                                                      2024-04-18
                                                      spl set id
                                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                      spl version
                                                      1
                                                      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. NDA021959
                                                      brand names
                                                      1. prednisolone sodium phosphate ODT
                                                      classification reasons
                                                      1. no_unambiguous_positive_indication_predicate
                                                      clinical review status
                                                      pending
                                                      content role
                                                      unclassified_context
                                                      context span
                                                      end
                                                      2323
                                                      end exclusive
                                                      true
                                                      exact text
                                                      d with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary
                                                      label id
                                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                      start
                                                      1837
                                                      current approval status
                                                      not_reconciled
                                                      duplicate text group
                                                      dup-60a65ae4f66917ffca82
                                                      extraction review status
                                                      automated_candidate_pending_source_review
                                                      generic names
                                                      1. PREDNISOLONE SODIUM PHOSPHATE
                                                      id
                                                      ind-span-3c33ca8b2df196ea3668
                                                      label id
                                                      ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                      positive predicate support span
                                                      Source null
                                                      qualifier mentions
                                                        regulatory links
                                                          schema version
                                                          0.1.0
                                                          source batch sha256
                                                          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                          source defined aliases
                                                            source span
                                                            end
                                                            2123
                                                            end exclusive
                                                            true
                                                            exact text
                                                            1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection
                                                            label id
                                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                            start
                                                            2037
                                                            source url
                                                            https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                            spl effective date
                                                            2024-04-18
                                                            spl set id
                                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                            spl version
                                                            1
                                                            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. NDA021959
                                                            brand names
                                                            1. prednisolone sodium phosphate ODT
                                                            classification reasons
                                                            1. no_unambiguous_positive_indication_predicate
                                                            clinical review status
                                                            pending
                                                            content role
                                                            unclassified_context
                                                            context span
                                                            end
                                                            2933
                                                            end exclusive
                                                            true
                                                            exact text
                                                            itions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Hypersensitivity pneumonitis Idiopathic bronchiolitis obliterans with organizing pneumonia Idiopathic eosinophilic pneumonias Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions A
                                                            label id
                                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                            start
                                                            1924
                                                            current approval status
                                                            not_reconciled
                                                            duplicate text group
                                                            dup-11b483affa33732fedb4
                                                            extraction review status
                                                            automated_candidate_pending_source_review
                                                            generic names
                                                            1. PREDNISOLONE SODIUM PHOSPHATE
                                                            id
                                                            ind-span-c284ab199226184ac28b
                                                            label id
                                                            ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                            positive predicate support span
                                                            Source null
                                                            qualifier mentions
                                                              regulatory links
                                                                schema version
                                                                0.1.0
                                                                source batch sha256
                                                                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                source defined aliases
                                                                  source span
                                                                  end
                                                                  2733
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Hypersensitivity pneumonitis Idiopathic bronchiolitis obliterans with organizing pneumonia Idiopathic eosinophilic pneumonias Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics Symptomatic sarcoidosis
                                                                  label id
                                                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                  start
                                                                  2124
                                                                  source url
                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                                  spl effective date
                                                                  2024-04-18
                                                                  spl set id
                                                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                  spl version
                                                                  1
                                                                  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. NDA021959
                                                                  brand names
                                                                  1. prednisolone sodium phosphate ODT
                                                                  classification reasons
                                                                  1. no_unambiguous_positive_indication_predicate
                                                                  clinical review status
                                                                  pending
                                                                  content role
                                                                  unclassified_context
                                                                  context span
                                                                  end
                                                                  3101
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  ry fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as ma
                                                                  label id
                                                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                  start
                                                                  2534
                                                                  current approval status
                                                                  not_reconciled
                                                                  duplicate text group
                                                                  dup-4615f81d093f7b12f7a2
                                                                  extraction review status
                                                                  automated_candidate_pending_source_review
                                                                  generic names
                                                                  1. PREDNISOLONE SODIUM PHOSPHATE
                                                                  id
                                                                  ind-span-40988c8737453d8eb8c2
                                                                  label id
                                                                  ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                  positive predicate support span
                                                                  Source null
                                                                  qualifier mentions
                                                                    regulatory links
                                                                      schema version
                                                                      0.1.0
                                                                      source batch sha256
                                                                      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                      source defined aliases
                                                                        source span
                                                                        end
                                                                        2901
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
                                                                        label id
                                                                        ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                        start
                                                                        2734
                                                                        source url
                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                                        spl effective date
                                                                        2024-04-18
                                                                        spl set id
                                                                        ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                        spl version
                                                                        1
                                                                        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. NDA021959
                                                                        brand names
                                                                        1. prednisolone sodium phosphate ODT
                                                                        classification reasons
                                                                        1. no_unambiguous_positive_indication_predicate
                                                                        clinical review status
                                                                        pending
                                                                        content role
                                                                        unclassified_context
                                                                        context span
                                                                        end
                                                                        3658
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        biotics Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Ankylosing spondylitis Dermatomyositis/polymyositis Polymyalgia rheumatica/temporal arteritis Psoriatic arthritis Relapsing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis 1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituber
                                                                        label id
                                                                        ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                        start
                                                                        2702
                                                                        current approval status
                                                                        not_reconciled
                                                                        duplicate text group
                                                                        dup-67f54cb6158a0d1e1feb
                                                                        extraction review status
                                                                        automated_candidate_pending_source_review
                                                                        generic names
                                                                        1. PREDNISOLONE SODIUM PHOSPHATE
                                                                        id
                                                                        ind-span-ce2c55522d82185eb7ec
                                                                        label id
                                                                        ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                        positive predicate support span
                                                                        Source null
                                                                        qualifier mentions
                                                                          regulatory links
                                                                            schema version
                                                                            0.1.0
                                                                            source batch sha256
                                                                            24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                            source defined aliases
                                                                              source span
                                                                              end
                                                                              3458
                                                                              end exclusive
                                                                              true
                                                                              exact text
                                                                              1.12 Rheumatologic Conditions As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Ankylosing spondylitis Dermatomyositis/polymyositis Polymyalgia rheumatica/temporal arteritis Psoriatic arthritis Relapsing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis
                                                                              label id
                                                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                              start
                                                                              2902
                                                                              source url
                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                                              spl effective date
                                                                              2024-04-18
                                                                              spl set id
                                                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                              spl version
                                                                              1
                                                                              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. NDA021959
                                                                              brand names
                                                                              1. prednisolone sodium phosphate ODT
                                                                              classification reasons
                                                                              1. no_unambiguous_positive_indication_predicate
                                                                              clinical review status
                                                                              pending
                                                                              content role
                                                                              unclassified_context
                                                                              context span
                                                                              end
                                                                              3677
                                                                              end exclusive
                                                                              true
                                                                              exact text
                                                                              psing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis 1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituberculous chemotherapy
                                                                              label id
                                                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                              start
                                                                              3259
                                                                              current approval status
                                                                              not_reconciled
                                                                              duplicate text group
                                                                              dup-750b1a8d6f41bbbbf241
                                                                              extraction review status
                                                                              automated_candidate_pending_source_review
                                                                              generic names
                                                                              1. PREDNISOLONE SODIUM PHOSPHATE
                                                                              id
                                                                              ind-span-eee8d98b425294045c7c
                                                                              label id
                                                                              ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                              positive predicate support span
                                                                              Source null
                                                                              qualifier mentions
                                                                                regulatory links
                                                                                  schema version
                                                                                  0.1.0
                                                                                  source batch sha256
                                                                                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                  source defined aliases
                                                                                    source span
                                                                                    end
                                                                                    3677
                                                                                    end exclusive
                                                                                    true
                                                                                    exact text
                                                                                    1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituberculous chemotherapy
                                                                                    label id
                                                                                    ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                                    offset unit
                                                                                    unicode_code_points
                                                                                    source array index
                                                                                    0
                                                                                    source field
                                                                                    indications_and_usage_exact
                                                                                    source text sha256
                                                                                    460e9fb9c4ce1e37cf9c9bf3f6e40c2724f9d60f5a977426966ba0d7031db4a1
                                                                                    start
                                                                                    3459
                                                                                    source url
                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22ebbc1751-9381-4db1-89ff-ae5a2963fb2c%22
                                                                                    spl effective date
                                                                                    2024-04-18
                                                                                    spl set id
                                                                                    ebbc1751-9381-4db1-89ff-ae5a2963fb2c
                                                                                    spl version
                                                                                    1
                                                                                    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