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LABELS · 7cee3688-8836-430a-b135-8922daf84dce

Targretin

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
2020-04-30
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: BIRTH DEFECTS TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning. TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ( 8.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA021055
boxed warning exact
  1. WARNING: BIRTH DEFECTS TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning. TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. TARGRETIN must not be administered to a pregnant woman. ( 8.1 )
brand names
  1. Targretin
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d056725-0576-4338-8089-6336e768ccdc
generic names
  1. BEXAROTENE
id
7cee3688-8836-430a-b135-8922daf84dce
indications and usage exact
  1. 1 INDICATIONS AND USAGE TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Bausch Health US, LLC
    matched search terms
    1. lymphoma
    package ndcs
    1. 0187-5526-75
    product ndcs
    1. 0187-5526
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 261349
      2. 308725
      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
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      skip
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      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%227cee3688-8836-430a-b135-8922daf84dce%22
      spl effective date
      2020-04-30
      spl effective time
      20200430
      spl set id
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      spl version
      16
      substance names
      1. BEXAROTENE
      uniis
      1. A61RXM4375
      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
        NDA021055
        payload
        all indexed label documents
        1. Appl No
          021055
          Application Docs Date
          2003-04-28 00:00:00
          Application Docs ID
          14253
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        2. Appl No
          021055
          Application Docs Date
          2014-03-26 00:00:00
          Application Docs ID
          14254
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        3. Appl No
          021055
          Application Docs Date
          2015-08-04 00:00:00
          Application Docs ID
          14255
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        4. Appl No
          021055
          Application Docs Date
          1999-12-29 00:00:00
          Application Docs ID
          35987
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        5. Appl No
          021055
          Application Docs Date
          2003-04-28 00:00:00
          Application Docs ID
          35988
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        6. Appl No
          021055
          Application Docs Date
          2011-05-18 00:00:00
          Application Docs ID
          35989
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021055
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1999-12-29 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          021055
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2001-02-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021055
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2003-04-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021055
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2003-04-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021055
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2002-01-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021055
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2011-05-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021055
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2012-01-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021055
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2014-12-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          021055
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2015-07-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          021055
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2015-09-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA021055
        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
        2015-09-14
        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
          021055
          Application Docs Date
          2015-08-04 00:00:00
          Application Docs ID
          14255
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
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        official application record
        Appl No
        021055
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAUSCH
        openfda application present
        true
        products
        1. Active Ingredient
          BEXAROTENE
          Appl No
          021055
          Drug Name
          TARGRETIN
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          75MG
          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. NDA021055
      brand names
      1. Targretin
      classification reasons
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      clinical review status
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      true
      exact text
      1 INDICATIONS AND USAGE TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )
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        end exclusive
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      2. context exact
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        end exclusive
        true
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        prior systemic therapy
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      regulatory links
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          1 INDICATIONS AND USAGE TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
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          source url
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          spl effective date
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          spl set id
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          structured fields status
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          tumor_directed_candidate
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          application numbers
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          end exclusive
          true
          exact text
          USAGE TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )
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          positive predicate support span
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          end exclusive
          true
          exact text
          is a retinoid indicated
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          qualifier mentions
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          2. context exact
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          3. context exact
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                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear

                    Preserved source evidence · Not medical advice