Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · bf273433-d76e-4071-99a9-a71caf064734

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
2026-06-24
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING and MYELOSUPPRESSION. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Severe renal toxicities are dose-related and cumulative. Ensure adequate hydration and monitor renal function and electrolytes. Consider dose reductions or alternative treatments in patients with renal impairment [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )]. • Peripheral Neuropathy: cisplatin for injection can cause dose-related peripheral neuropathy that becomes more severe with repeated courses of the drug [see Warnings and Precautions ( 5.2 )]. • Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Use highly effective antiemetic premedication [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.3 )]. • Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts accordingly. Interruption of therapy may be required [see Warnings and Precautions ( 5.4 )]. WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING, and MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Ensure adequate hydration. Consider dose reductions or alternative treatments in patients with renal impairment. ( 2.1 , 5.1 ) • Peripheral Neuropathy: cisplatin for injection can cause dose-related peripheral neuropathy. ( 5.2 ) • Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Premedicate with antiemetics. ( 2.1 , 5.3 ) • Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts and interrupt therapy accordingly. ( 5.4 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
Full extracted label fields
application numbers
  1. NDA018057
boxed warning exact
  1. WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING and MYELOSUPPRESSION. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Severe renal toxicities are dose-related and cumulative. Ensure adequate hydration and monitor renal function and electrolytes. Consider dose reductions or alternative treatments in patients with renal impairment [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )]. • Peripheral Neuropathy: cisplatin for injection can cause dose-related peripheral neuropathy that becomes more severe with repeated courses of the drug [see Warnings and Precautions ( 5.2 )]. • Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Use highly effective antiemetic premedication [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.3 )]. • Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts accordingly. Interruption of therapy may be required [see Warnings and Precautions ( 5.4 )]. WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, NAUSEA AND VOMITING, and MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Ensure adequate hydration. Consider dose reductions or alternative treatments in patients with renal impairment. ( 2.1 , 5.1 ) • Peripheral Neuropathy: cisplatin for injection can cause dose-related peripheral neuropathy. ( 5.2 ) • Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Premedicate with antiemetics. ( 2.1 , 5.3 ) • Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts and interrupt therapy accordingly. ( 5.4 )
brand names
  1. Cisplatin
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=508496cb-3441-46b3-a4fe-e0d440e6adc6
generic names
  1. CISPLATIN
id
bf273433-d76e-4071-99a9-a71caf064734
indications and usage exact
  1. 1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. WG Critical Care, LLC
    matched search terms
    1. cancer
    package ndcs
    1. 44567-530-01
    product ndcs
    1. 44567-530
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1736854
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.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
      600
      total
      830
      sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      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=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
      spl effective date
      2026-06-24
      spl effective time
      20260624
      spl set id
      508496cb-3441-46b3-a4fe-e0d440e6adc6
      spl version
      4
      substance names
      1. CISPLATIN
      uniis
      1. Q20Q21Q62J
      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
        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
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      304
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advan
      label id
      bf273433-d76e-4071-99a9-a71caf064734
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-177a63ed299de45a6978
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. CISPLATIN
      id
      ind-span-7d2660ea07753ce8ad42
      label id
      bf273433-d76e-4071-99a9-a71caf064734
      positive predicate support span
      end
      82
      end exclusive
      true
      exact text
      is a platinum-based drug indicated
      label id
      bf273433-d76e-4071-99a9-a71caf064734
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
      start
      48
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
          source defined aliases
            source span
            end
            104
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of:
            label id
            bf273433-d76e-4071-99a9-a71caf064734
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
            spl effective date
            2026-06-24
            spl set id
            508496cb-3441-46b3-a4fe-e0d440e6adc6
            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
            non_oncology_or_unclear_candidate
            Passage 2 · unclassified context
            application numbers
            1. NDA018057
            brand names
            1. Cisplatin
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            341
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced O
            label id
            bf273433-d76e-4071-99a9-a71caf064734
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-bde05b3854c6ec4420e8
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. CISPLATIN
            id
            ind-span-cd0c5210bd39da112fb2
            label id
            bf273433-d76e-4071-99a9-a71caf064734
            positive predicate support span
            Source null
            qualifier mentions
            1. context exact
              • Advanced testicular cancer ( 1.1 )
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              137
              end exclusive
              true
              exact text
              Advanced testicular cancer ( 1
              label id
              bf273433-d76e-4071-99a9-a71caf064734
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
              start
              107
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
              source defined aliases
                source span
                end
                141
                end exclusive
                true
                exact text
                • Advanced testicular cancer ( 1.1 )
                label id
                bf273433-d76e-4071-99a9-a71caf064734
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                start
                105
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                spl effective date
                2026-06-24
                spl set id
                508496cb-3441-46b3-a4fe-e0d440e6adc6
                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
                unclear
                Passage 3 · unclassified context
                application numbers
                1. NDA018057
                brand names
                1. Cisplatin
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                375
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for inject
                label id
                bf273433-d76e-4071-99a9-a71caf064734
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                start
                0
                current approval status
                not_reconciled
                duplicate text group
                dup-3a29be651b3b43de835c
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. CISPLATIN
                id
                ind-span-c86293fd616433d9a8e6
                label id
                bf273433-d76e-4071-99a9-a71caf064734
                positive predicate support span
                Source null
                qualifier mentions
                1. context exact
                  • Advanced ovarian cancer ( 1.2 )
                  kind
                  stage_or_setting
                  polarity
                  not_inferred
                  span
                  end
                  171
                  end exclusive
                  true
                  exact text
                  Advanced ovarian cancer ( 1
                  label id
                  bf273433-d76e-4071-99a9-a71caf064734
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                  start
                  144
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                  source defined aliases
                    source span
                    end
                    175
                    end exclusive
                    true
                    exact text
                    • Advanced ovarian cancer ( 1.2 )
                    label id
                    bf273433-d76e-4071-99a9-a71caf064734
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                    start
                    142
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                    spl effective date
                    2026-06-24
                    spl set id
                    508496cb-3441-46b3-a4fe-e0d440e6adc6
                    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
                    unclear
                    Passage 4 · unclassified context
                    application numbers
                    1. NDA018057
                    brand names
                    1. Cisplatin
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    409
                    end exclusive
                    true
                    exact text
                    1 INDICATIONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment
                    label id
                    bf273433-d76e-4071-99a9-a71caf064734
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                    start
                    0
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-e7779420913ed0b0b233
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. CISPLATIN
                    id
                    ind-span-351b3d75dadf22aac80e
                    label id
                    bf273433-d76e-4071-99a9-a71caf064734
                    positive predicate support span
                    Source null
                    qualifier mentions
                    1. context exact
                      • Advanced bladder cancer ( 1.3 )
                      kind
                      stage_or_setting
                      polarity
                      not_inferred
                      span
                      end
                      205
                      end exclusive
                      true
                      exact text
                      Advanced bladder cancer ( 1
                      label id
                      bf273433-d76e-4071-99a9-a71caf064734
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                      start
                      178
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                      source defined aliases
                        source span
                        end
                        209
                        end exclusive
                        true
                        exact text
                        • Advanced bladder cancer ( 1.3 )
                        label id
                        bf273433-d76e-4071-99a9-a71caf064734
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                        start
                        176
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                        spl effective date
                        2026-06-24
                        spl set id
                        508496cb-3441-46b3-a4fe-e0d440e6adc6
                        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
                        unclear
                        Passage 5 · positive indication candidate
                        application numbers
                        1. NDA018057
                        brand names
                        1. Cisplatin
                        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
                        526
                        end exclusive
                        true
                        exact text
                        ONS AND USAGE Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of ad
                        label id
                        bf273433-d76e-4071-99a9-a71caf064734
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                        start
                        10
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-74d440469e42589dd5c2
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. CISPLATIN
                        id
                        ind-span-ec1be38a6fff2463825c
                        label id
                        bf273433-d76e-4071-99a9-a71caf064734
                        positive predicate support span
                        end
                        277
                        end exclusive
                        true
                        exact text
                        is indicated
                        label id
                        bf273433-d76e-4071-99a9-a71caf064734
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                        start
                        265
                        qualifier mentions
                        1. context exact
                          1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicula
                          kind
                          stage_or_setting
                          polarity
                          not_inferred
                          span
                          end
                          257
                          end exclusive
                          true
                          exact text
                          Advanced Testicular Cancer Cisplatin for in
                          label id
                          bf273433-d76e-4071-99a9-a71caf064734
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                          start
                          214
                        2. context exact
                          r Cisplatin for injection is indicated for the treatment of advanced testicular cancer.
                          kind
                          stage_or_setting
                          polarity
                          not_inferred
                          span
                          end
                          325
                          end exclusive
                          true
                          exact text
                          advanced testicular cancer
                          label id
                          bf273433-d76e-4071-99a9-a71caf064734
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                          start
                          299
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                          source defined aliases
                            source span
                            end
                            326
                            end exclusive
                            true
                            exact text
                            1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer.
                            label id
                            bf273433-d76e-4071-99a9-a71caf064734
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                            start
                            210
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                            spl effective date
                            2026-06-24
                            spl set id
                            508496cb-3441-46b3-a4fe-e0d440e6adc6
                            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
                            Passage 6 · positive indication candidate
                            application numbers
                            1. NDA018057
                            brand names
                            1. Cisplatin
                            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
                            548
                            end exclusive
                            true
                            exact text
                            cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
                            label id
                            bf273433-d76e-4071-99a9-a71caf064734
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                            start
                            127
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-560612e27809bb4a9ca4
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. CISPLATIN
                            id
                            ind-span-c4dfad92f92772bdf262
                            label id
                            bf273433-d76e-4071-99a9-a71caf064734
                            positive predicate support span
                            end
                            391
                            end exclusive
                            true
                            exact text
                            is indicated
                            label id
                            bf273433-d76e-4071-99a9-a71caf064734
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                            start
                            379
                            qualifier mentions
                            1. context exact
                              1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian canc
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              374
                              end exclusive
                              true
                              exact text
                              Advanced Ovarian Cancer Cisplatin for injec
                              label id
                              bf273433-d76e-4071-99a9-a71caf064734
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                              start
                              331
                            2. context exact
                              r Cisplatin for injection is indicated for the treatment of advanced ovarian cancer.
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              436
                              end exclusive
                              true
                              exact text
                              advanced ovarian cancer
                              label id
                              bf273433-d76e-4071-99a9-a71caf064734
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                              start
                              413
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                              source defined aliases
                                source span
                                end
                                437
                                end exclusive
                                true
                                exact text
                                1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer.
                                label id
                                bf273433-d76e-4071-99a9-a71caf064734
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                start
                                327
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                                spl effective date
                                2026-06-24
                                spl set id
                                508496cb-3441-46b3-a4fe-e0d440e6adc6
                                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
                                Passage 7 · positive indication candidate
                                application numbers
                                1. NDA018057
                                brand names
                                1. Cisplatin
                                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
                                548
                                end exclusive
                                true
                                exact text
                                er Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
                                label id
                                bf273433-d76e-4071-99a9-a71caf064734
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                start
                                238
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-1278cdca56f85ced8770
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. CISPLATIN
                                id
                                ind-span-0f9c7c49aa645c342753
                                label id
                                bf273433-d76e-4071-99a9-a71caf064734
                                positive predicate support span
                                end
                                502
                                end exclusive
                                true
                                exact text
                                is indicated
                                label id
                                bf273433-d76e-4071-99a9-a71caf064734
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                start
                                490
                                qualifier mentions
                                1. context exact
                                  1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder canc
                                  kind
                                  stage_or_setting
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  485
                                  end exclusive
                                  true
                                  exact text
                                  Advanced Bladder Cancer Cisplatin for injec
                                  label id
                                  bf273433-d76e-4071-99a9-a71caf064734
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                  start
                                  442
                                2. context exact
                                  r Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
                                  kind
                                  stage_or_setting
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  547
                                  end exclusive
                                  true
                                  exact text
                                  advanced bladder cancer
                                  label id
                                  bf273433-d76e-4071-99a9-a71caf064734
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                  start
                                  524
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                  source defined aliases
                                    source span
                                    end
                                    548
                                    end exclusive
                                    true
                                    exact text
                                    1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
                                    label id
                                    bf273433-d76e-4071-99a9-a71caf064734
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    ffc0aa5c9f3ca25f578ababc3b276f3170b6aef6380dc534f56f904eb76646fc
                                    start
                                    438
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%22bf273433-d76e-4071-99a9-a71caf064734%22
                                    spl effective date
                                    2026-06-24
                                    spl set id
                                    508496cb-3441-46b3-a4fe-e0d440e6adc6
                                    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