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LABELS · e61c29ce-16b2-415c-b203-28bc9d45bb5f

Metyrosine

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
2021-07-01
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
Full extracted label fields
application numbers
  1. NDA017871
boxed warning exact
    brand names
    1. Metyrosine
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46612725-bee0-4125-b8b5-9fed9c003ed4
    generic names
    1. METYROSINE
    id
    e61c29ce-16b2-415c-b203-28bc9d45bb5f
    indications and usage exact
    1. INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Oceanside Pharmaceuticals
      matched search terms
      1. malignant
      2. pheochromocytoma
      package ndcs
      1. 68682-310-01
      product ndcs
      1. 68682-310
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 197980
        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%22e61c29ce-16b2-415c-b203-28bc9d45bb5f%22
        spl effective date
        2021-07-01
        spl effective time
        20210701
        spl set id
        46612725-bee0-4125-b8b5-9fed9c003ed4
        spl version
        4
        substance names
        1. METYROSINE
        uniis
        1. DOQ0J0TPF7
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
        3. individual_indications_not_split_or_reconciled
        Drugs@FDA application source records
        1. application number
          NDA017871
          payload
          all indexed label documents
            all submission records
            1. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1979-10-03 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              1980-11-14 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              1984-01-25 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              017871
              Review Priority
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              1985-09-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              017871
              Review Priority
              Submission Class Code ID
              3
              Submission No
              6
              Submission Status
              AP
              Submission Status Date
              1985-11-01 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              1988-07-07 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              1987-12-23 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              1994-03-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              10
              Submission Status
              AP
              Submission Status Date
              2001-12-12 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              017871
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              11
              Submission Status
              AP
              Submission Status Date
              2003-05-30 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              18
              Submission Status
              AP
              Submission Status Date
              2013-11-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              017871
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              19
              Submission Status
              AP
              Submission Status Date
              2014-07-15 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA017871
            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
            2014-07-15
            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
              official application record
              Appl No
              017871
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              BAUSCH
              openfda application present
              true
              products
              1. Active Ingredient
                METYROSINE
                Appl No
                017871
                Drug Name
                DEMSER
                Form
                CAPSULE;ORAL
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                250MG
                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. NDA017871
            brand names
            1. Metyrosine
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            304
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommend
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            duplicate text group
            dup-49917d0819932098e922
            extraction review status
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            generic names
            1. METYROSINE
            id
            ind-span-55010a1bbbd1b2532a72
            label id
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            positive predicate support span
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            end exclusive
            true
            exact text
            is indicated
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            start
            33
            qualifier mentions
            1. context exact
              INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1.
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              65
              end exclusive
              true
              exact text
              Metyrosine is indicated in the treatment of
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            regulatory links
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                end exclusive
                true
                exact text
                INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1.
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                offset unit
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                start
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                source url
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                spl effective date
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                spl set id
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                spl version
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                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
                tumor_directed_candidate
                Passage 2 · unclassified context
                application numbers
                1. NDA017871
                brand names
                1. Metyrosine
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
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                349
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
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                label id
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                positive predicate support span
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                  regulatory links
                    schema version
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                    source defined aliases
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                      end exclusive
                      true
                      exact text
                      Preoperative preparation of patients for surgery 2.
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                      e61c29ce-16b2-415c-b203-28bc9d45bb5f
                      offset unit
                      unicode_code_points
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                      source field
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                      source text sha256
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                      source url
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                      spl effective date
                      2021-07-01
                      spl set id
                      46612725-bee0-4125-b8b5-9fed9c003ed4
                      spl version
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                      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 · risk or warning
                      application numbers
                      1. NDA017871
                      brand names
                      1. Metyrosine
                      classification reasons
                      1. risk_or_warning_words_without_positive_predicate
                      clinical review status
                      pending
                      content role
                      risk_or_warning
                      context span
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                      349
                      end exclusive
                      true
                      exact text
                      INDICATIONS AND USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
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                      generic names
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                            214
                            end exclusive
                            true
                            exact text
                            Management of patients when surgery is contraindicated 3.
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                            e61c29ce-16b2-415c-b203-28bc9d45bb5f
                            offset unit
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                            source text sha256
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                            157
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22e61c29ce-16b2-415c-b203-28bc9d45bb5f%22
                            spl effective date
                            2021-07-01
                            spl set id
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                            spl version
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                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            not_applicable
                            Passage 4 · limitation of use
                            application numbers
                            1. NDA017871
                            brand names
                            1. Metyrosine
                            classification reasons
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                            clinical review status
                            pending
                            content role
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                            context span
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                            349
                            end exclusive
                            true
                            exact text
                            USAGE Metyrosine is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
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                            label id
                            e61c29ce-16b2-415c-b203-28bc9d45bb5f
                            positive predicate support span
                            Source null
                            qualifier mentions
                            1. context exact
                              ronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
                              kind
                              biomarker
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                              320
                              end exclusive
                              true
                              exact text
                              Metyrosine is not recommended for the contr
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                                349
                                end exclusive
                                true
                                exact text
                                Chronic treatment of patients with malignant pheochromocytoma Metyrosine is not recommended for the control of essential hypertension.
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                                source text sha256
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                                source url
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                                spl effective date
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                                structured fields status
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                                structured indication
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                                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
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                                Preserved source evidence · Not medical advice