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LABELS · dd45d777-d4c1-40ee-b4f0-c9e001a15a8c

CISplatin

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
2021-09-16
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING Cisplatin Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections). Exercise caution to prevent inadvertent cisplatin overdose. Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.

Indications and usage: exact source text

  1. INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.
Full extracted label fields
application numbers
  1. NDA018057
boxed warning exact
  1. WARNING Cisplatin Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections). Exercise caution to prevent inadvertent cisplatin overdose. Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
brand names
  1. CISplatin
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bf8d2fb-80c8-401d-8e9b-d58463f5e954
generic names
  1. CISPLATIN
id
dd45d777-d4c1-40ee-b4f0-c9e001a15a8c
indications and usage exact
  1. INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. WG Critical Care, LLC
    matched search terms
    1. cancer
    2. tumors
    package ndcs
    1. 44567-509-01
    2. 44567-510-01
    3. 44567-511-01
    product ndcs
    1. 44567-509
    2. 44567-510
    3. 44567-511
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 309311
      source batch
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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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      2026-09-09
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      url
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      source url
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      spl effective date
      2021-09-16
      spl effective time
      20210916
      spl set id
      2bf8d2fb-80c8-401d-8e9b-d58463f5e954
      spl version
      5
      substance names
      1. CISPLATIN
      uniis
      1. Q20Q21Q62J
      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA018057
        payload
        all indexed label documents
        1. Appl No
          018057
          Application Docs Date
          2010-09-07 00:00:00
          Application Docs ID
          11135
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          79
          Submission Type
          SUPPL
        2. Appl No
          018057
          Application Docs Date
          2011-08-30 00:00:00
          Application Docs ID
          11136
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          80
          Submission Type
          SUPPL
        3. Appl No
          018057
          Application Docs Date
          2015-03-02 00:00:00
          Application Docs ID
          11137
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          83
          Submission Type
          SUPPL
        4. Appl No
          018057
          Application Docs Date
          2012-01-11 00:00:00
          Application Docs ID
          33407
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          81
          Submission Type
          SUPPL
        5. Appl No
          018057
          Application Docs Date
          2019-02-25 00:00:00
          Application Docs ID
          57798
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          89
          Submission Type
          SUPPL
        6. Appl No
          018057
          Application Docs Date
          2022-05-23 00:00:00
          Application Docs ID
          71121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          92
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          018057
          Review Priority
          Submission Class Code ID
          3
          Submission No
          46
          Submission Status
          AP
          Submission Status Date
          1987-04-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          1988-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          018057
          Review Priority
          Submission Class Code ID
          3
          Submission No
          49
          Submission Status
          AP
          Submission Status Date
          1989-03-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          1988-01-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          018057
          Review Priority
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          1990-12-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          52
          Submission Status
          AP
          Submission Status Date
          1990-04-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          53
          Submission Status
          AP
          Submission Status Date
          1991-11-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          55
          Submission Status
          AP
          Submission Status Date
          1990-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          018057
          Review Priority
          Submission Class Code ID
          3
          Submission No
          56
          Submission Status
          AP
          Submission Status Date
          1992-07-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          57
          Submission Status
          AP
          Submission Status Date
          1991-07-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          58
          Submission Status
          AP
          Submission Status Date
          1990-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          018057
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          59
          Submission Status
          AP
          Submission Status Date
          1991-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA018057
        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
        2022-03-24
        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
          018057
          Application Docs Date
          2022-05-23 00:00:00
          Application Docs ID
          71121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          92
          Submission Type
          SUPPL
        official application record
        Appl No
        018057
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HQ SPCLT PHARMA
        openfda application present
        true
        products
        1. Active Ingredient
          CISPLATIN
          Appl No
          018057
          Drug Name
          PLATINOL
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          10MG/VIAL
          marketing status
          1. Discontinued
        2. Active Ingredient
          CISPLATIN
          Appl No
          018057
          Drug Name
          CISPLATIN
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          50MG/VIAL
          marketing status
          1. Prescription
        3. Active Ingredient
          CISPLATIN
          Appl No
          018057
          Drug Name
          PLATINOL-AQ
          Form
          INJECTABLE;INJECTION
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          0.5MG/ML
          marketing status
          1. Discontinued
        4. Active Ingredient
          CISPLATIN
          Appl No
          018057
          Drug Name
          CISPLATIN
          Form
          INJECTABLE;INJECTION
          Product No
          004
          Reference Drug
          1
          Reference Standard
          0
          Strength
          1MG/ML
          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. NDA018057
      brand names
      1. CISplatin
      classification reasons
      1. explicit_positive_indication_predicate
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      clinical review status
      pending
      content role
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      context span
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      true
      exact text
      INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/
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      not_reconciled
      duplicate text group
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      1. CISPLATIN
      id
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        biomarker
        polarity
        not_inferred
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        exact text
        Metastatic Testicular Tumors In established
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        metastatic testicular tumors who have alrea
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        Metastatic Testicular Tumors In established c
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        metastatic testicular tumors who have already
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      regulatory links
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        source defined aliases
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          exact text
          INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.
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          source url
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          spl effective date
          2021-09-16
          spl set id
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          spl version
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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
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
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          lished combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors r
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            kind
            biomarker
            polarity
            not_inferred
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            Metastatic Ovarian Tumors In established co
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            metastatic ovarian tumors who have already
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