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LABELS · b23b46f5-c276-47f5-8bbd-940680b3f579

HYCAMTIN

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
2023-09-18
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1)] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts of greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.2 , 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
Full extracted label fields
application numbers
  1. NDA020981
boxed warning exact
  1. WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1)] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts of greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.2 , 5.1 ).
brand names
  1. HYCAMTIN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b23b46f5-c276-47f5-8bbd-940680b3f579
generic names
  1. TOPOTECAN
id
b23b46f5-c276-47f5-8bbd-940680b3f579
indications and usage exact
  1. 1 INDICATIONS AND USAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Sandoz Inc
    matched search terms
    1. cancer
    package ndcs
    1. 66758-101-11
    2. 66758-102-11
    product ndcs
    1. 66758-101
    2. 66758-102
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      routes
      1. ORAL
      rxcuis
      1. 747193
      2. 747195
      3. 748738
      4. 748740
      source batch
      file
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      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.
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      url
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      source url
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      spl effective date
      2023-09-18
      spl effective time
      20230918
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      spl version
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      substance names
      1. TOPOTECAN HYDROCHLORIDE
      uniis
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      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA020981
        payload
        all indexed label documents
        1. Appl No
          020981
          Application Docs Date
          2007-10-12 00:00:00
          Application Docs ID
          14079
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          020981
          Application Docs Date
          2010-07-06 00:00:00
          Application Docs ID
          14080
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          020981
          Application Docs Date
          2011-10-12 00:00:00
          Application Docs ID
          14081
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          020981
          Application Docs Date
          2014-06-23 00:00:00
          Application Docs ID
          35783
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          020981
          Application Docs Date
          2018-09-06 00:00:00
          Application Docs ID
          55391
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020981
          Review Priority
          PRIORITY
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2007-10-11 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          020981
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2008-09-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2010-06-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020981
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2011-10-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2014-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2018-09-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA020981
        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
        2018-09-05
        latest label selection rule
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        latest posted label documents
        1. Appl No
          020981
          Application Docs Date
          2018-09-06 00:00:00
          Application Docs ID
          55391
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          8
          Submission Type
          SUPPL
        official application record
        Appl No
        020981
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        SANDOZ
        openfda application present
        true
        products
        1. Active Ingredient
          TOPOTECAN HYDROCHLORIDE
          Appl No
          020981
          Drug Name
          HYCAMTIN
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 0.25MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          TOPOTECAN HYDROCHLORIDE
          Appl No
          020981
          Drug Name
          HYCAMTIN
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 1MG 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
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      brand names
      1. HYCAMTIN
      classification reasons
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      clinical review status
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      true
      exact text
      1 INDICATIONS AND USAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
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      1. context exact
        SAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who ar
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          1 INDICATIONS AND USAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.
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          spl set id
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          s are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
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              HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).
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              e and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )
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                    Preserved source evidence · Not medical advice