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LABELS · d505027a-76e6-49f1-8ed1-3eeffe9a958b

IFOSFAMIDE

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2024-12-02
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ]. • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ]. • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ]. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning . • Myelosuppression can be severe and lead to fatal infections ( 5.1 ) • Encephalopathy can be severe and may result in death ( 5.2 ) • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. Ifosfamide for Injection is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA019763
boxed warning exact
  1. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ]. • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ]. • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ]. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning . • Myelosuppression can be severe and lead to fatal infections ( 5.1 ) • Encephalopathy can be severe and may result in death ( 5.2 ) • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )
brand names
  1. IFOSFAMIDE
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91e433a9-6800-43a6-ac13-a49a04a5aecd
generic names
  1. IFOSFAMIDE
id
d505027a-76e6-49f1-8ed1-3eeffe9a958b
indications and usage exact
  1. 1 INDICATIONS AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. Ifosfamide for Injection is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Baxter Healthcare Company
    matched search terms
    1. cancer
    package ndcs
    1. 10019-925-82
    2. 10019-925-01
    3. 10019-926-16
    4. 10019-926-02
    product ndcs
    1. 10019-925
    2. 10019-926
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 12/2024 Dosage and Administration (2.1, 2.2, 2.3) 12/2024 Warnings and Precautions (5) 12/2024
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1791588
    2. 1791593
    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
    https://api.fda.gov/drug/label.json?search=id%3A%22d505027a-76e6-49f1-8ed1-3eeffe9a958b%22
    spl effective date
    2024-12-02
    spl effective time
    20241202
    spl set id
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    spl version
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    substance names
    1. IFOSFAMIDE
    uniis
    1. UM20QQM95Y
    verification flags
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    Drugs@FDA application source records
    1. application number
      NDA019763
      payload
      all indexed label documents
      1. Appl No
        019763
        Application Docs Date
        2011-03-28 00:00:00
        Application Docs ID
        33914
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      2. Appl No
        019763
        Application Docs Date
        2012-03-06 00:00:00
        Application Docs ID
        33915
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      3. Appl No
        019763
        Application Docs Date
        2014-09-03 00:00:00
        Application Docs ID
        33916
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      4. Appl No
        019763
        Application Docs Date
        2018-08-02 00:00:00
        Application Docs ID
        55079
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        20
        Submission Type
        SUPPL
      5. Appl No
        019763
        Application Docs Date
        2024-12-03 00:00:00
        Application Docs ID
        80476
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2024-12-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        20
        Submission Status
        AP
        Submission Status Date
        2018-07-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2014-08-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2012-03-01 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2011-03-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2001-11-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2001-09-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        1996-12-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        019763
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        1996-01-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        1995-08-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        1995-06-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        019763
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        1992-11-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA019763
      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
      2024-12-02
      latest label selection rule
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      latest posted label documents
      1. Appl No
        019763
        Application Docs Date
        2024-12-03 00:00:00
        Application Docs ID
        80476
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      official application record
      Appl No
      019763
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      BAXTER HLTHCARE
      openfda application present
      true
      products
      1. Active Ingredient
        IFOSFAMIDE
        Appl No
        019763
        Drug Name
        IFEX
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        1GM/VIAL
        marketing status
        1. Prescription
      2. Active Ingredient
        IFOSFAMIDE
        Appl No
        019763
        Drug Name
        IFEX
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        3GM/VIAL
        marketing status
        1. Prescription
      3. Active Ingredient
        IFOSFAMIDE; MESNA
        Appl No
        019763
        Drug Name
        IFEX/MESNEX KIT
        Form
        INJECTABLE;INJECTION
        Product No
        003
        Reference Drug
        0
        Reference Standard
        0
        Strength
        1GM/VIAL;100MG/ML
        marketing status
        1. Discontinued
      4. Active Ingredient
        IFOSFAMIDE; MESNA
        Appl No
        019763
        Drug Name
        IFEX/MESNEX KIT
        Form
        INJECTABLE;INJECTION
        Product No
        004
        Reference Drug
        0
        Reference Standard
        0
        Strength
        3GM/VIAL;100MG/ML
        marketing status
        1. Discontinued

    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. IFOSFAMIDE
    classification reasons
    1. explicit_positive_indication_predicate
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    exact text
    1 INDICATIONS AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. Ifosfamide for Injection is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
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    1. IFOSFAMIDE
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      AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic a
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        1 INDICATIONS AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
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        ICATIONS AND USAGE Ifosfamide for Injection is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. Ifosfamide for Injection is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. ( 1 )
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            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 3 · unclassified context
            application numbers
            1. NDA019763
            brand names
            1. IFOSFAMIDE
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            410
            end exclusive
            true
            exact text
            Ifosfamide for Injection is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. ( 1 )
            label id
            d505027a-76e6-49f1-8ed1-3eeffe9a958b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e4d829eb8d020401f75f2d4093a87c6680a1c77387a964f0a64cdb02cedc6890
            start
            205
            current approval status
            not_reconciled
            duplicate text group
            dup-b4ba29fb2ab7b520fb03
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. IFOSFAMIDE
            id
            ind-span-1fffd166779ed3b96ebe
            label id
            d505027a-76e6-49f1-8ed1-3eeffe9a958b
            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                source defined aliases
                  source span
                  end
                  410
                  end exclusive
                  true
                  exact text
                  ( 1 )
                  label id
                  d505027a-76e6-49f1-8ed1-3eeffe9a958b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  e4d829eb8d020401f75f2d4093a87c6680a1c77387a964f0a64cdb02cedc6890
                  start
                  405
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22d505027a-76e6-49f1-8ed1-3eeffe9a958b%22
                  spl effective date
                  2024-12-02
                  spl set id
                  91e433a9-6800-43a6-ac13-a49a04a5aecd
                  spl version
                  17
                  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

                  Preserved source evidence · Not medical advice