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LABELS · 5e2a19b9-0694-43ac-9e0e-b40048495a1b

Salagen

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
2024-12-05
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
Full extracted label fields
application numbers
  1. NDA020237
boxed warning exact
    brand names
    1. Salagen
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62eda83d-d043-4c7e-8fcf-75d05efbf35b
    generic names
    1. PILOCARPINE HYDROCHLORIDE
    id
    5e2a19b9-0694-43ac-9e0e-b40048495a1b
    indications and usage exact
    1. INDICATIONS & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Advanz Pharma (US) Corp.
      matched search terms
      1. cancer
      package ndcs
      1. 59212-705-10
      2. 59212-775-10
      product ndcs
      1. 59212-705
      2. 59212-775
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1000913
        2. 1000915
        3. 1001004
        4. 1001006
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%225e2a19b9-0694-43ac-9e0e-b40048495a1b%22
        spl effective date
        2024-12-05
        spl effective time
        20241205
        spl set id
        62eda83d-d043-4c7e-8fcf-75d05efbf35b
        spl version
        4
        substance names
        1. PILOCARPINE HYDROCHLORIDE
        uniis
        1. 0WW6D218XJ
        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
          NDA020237
          payload
          all indexed label documents
          1. Appl No
            020237
            Application Docs Date
            2002-06-10 00:00:00
            Application Docs ID
            12350
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          2. Appl No
            020237
            Application Docs Date
            2003-04-28 00:00:00
            Application Docs ID
            12351
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          3. Appl No
            020237
            Application Docs Date
            2002-06-10 00:00:00
            Application Docs ID
            34410
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1994-03-22 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1996-04-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            1995-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            1995-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            1995-11-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020237
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            1996-09-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020237
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            1997-03-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020237
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            1998-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020237
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2002-06-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020237
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2002-06-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2000-02-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020237
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2002-09-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020237
          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
          2015-09-10
          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
            020237
            Application Docs Date
            2003-04-28 00:00:00
            Application Docs ID
            12351
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          official application record
          Appl No
          020237
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ADVANZ PHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            PILOCARPINE HYDROCHLORIDE
            Appl No
            020237
            Drug Name
            SALAGEN
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            5MG
            marketing status
            1. Prescription
          2. Active Ingredient
            PILOCARPINE HYDROCHLORIDE
            Appl No
            020237
            Drug Name
            SALAGEN
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            7.5MG
            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. NDA020237
        brand names
        1. Salagen
        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
        269
        end exclusive
        true
        exact text
        INDICATIONS & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
        label id
        5e2a19b9-0694-43ac-9e0e-b40048495a1b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        f1fc380c8a2f2d9d9d5079f8b63c3956d59261c609177a48828f8eed8017ece5
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-681c32ef04d436207a7a
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. PILOCARPINE HYDROCHLORIDE
        id
        ind-span-9ebb16fb4df44cbd7870
        label id
        5e2a19b9-0694-43ac-9e0e-b40048495a1b
        positive predicate support span
        end
        51
        end exclusive
        true
        exact text
        are indicated
        label id
        5e2a19b9-0694-43ac-9e0e-b40048495a1b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        f1fc380c8a2f2d9d9d5079f8b63c3956d59261c609177a48828f8eed8017ece5
        start
        38
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
            source defined aliases
              source span
              end
              269
              end exclusive
              true
              exact text
              INDICATIONS & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
              label id
              5e2a19b9-0694-43ac-9e0e-b40048495a1b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f1fc380c8a2f2d9d9d5079f8b63c3956d59261c609177a48828f8eed8017ece5
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%225e2a19b9-0694-43ac-9e0e-b40048495a1b%22
              spl effective date
              2024-12-05
              spl set id
              62eda83d-d043-4c7e-8fcf-75d05efbf35b
              spl version
              4
              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

              Preserved source evidence · Not medical advice