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LABELS · 4b8997a9-ddf8-4618-966a-291d583f24f7

KHAPZORY

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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
2026-03-17
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B 12 because of the risk of progression of neurologic manifestations despite hematologic remission. KHAPZORY is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adults and pediatric patients with osteosarcoma. ( 1 ) Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ( 1 ) Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. ( 1 ) Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.( 1 )
Full extracted label fields
application numbers
  1. NDA211226
boxed warning exact
    brand names
    1. KHAPZORY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=344f65ac-9f04-49d7-b7c3-4ba19bd7b429
    generic names
    1. LEVOLEUCOVORIN
    id
    4b8997a9-ddf8-4618-966a-291d583f24f7
    indications and usage exact
    1. 1 INDICATIONS AND USAGE KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B 12 because of the risk of progression of neurologic manifestations despite hematologic remission. KHAPZORY is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adults and pediatric patients with osteosarcoma. ( 1 ) Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ( 1 ) Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. ( 1 ) Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Acrotech Biopharma Inc
      matched search terms
      1. cancer
      package ndcs
      1. 72893-004-01
      product ndcs
      1. 72893-004
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1858561
        2. 2106373
        source batch
        file
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        meta
        disclaimer
        Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
        last updated
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        spl effective date
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        spl effective time
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        substance names
        1. LEVOLEUCOVORIN DISODIUM
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        Drugs@FDA application source records
        1. application number
          NDA211226
          payload
          all indexed label documents
          1. Appl No
            211226
            Application Docs Date
            2018-10-22 00:00:00
            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
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          2. Appl No
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            Application Docs Date
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            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
            9
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2018-10-19 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status
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            Submission Status Date
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            Submission Type
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            Submissions Public Notes
          application number
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          approval interpretation
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          current indication status
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          has approved submission record
          true
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          latest posted label documents
          1. Appl No
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            Application Docs Date
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            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          ACROTECH BIOPHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            LEVOLEUCOVORIN
            Appl No
            211226
            Drug Name
            KHAPZORY
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            175MG/VIAL
            marketing status
            1. Prescription
          2. Active Ingredient
            LEVOLEUCOVORIN
            Appl No
            211226
            Drug Name
            KHAPZORY
            Form
            POWDER;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            300MG/VIAL
            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
        1. NDA211226
        brand names
        1. KHAPZORY
        classification reasons
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        exact text
        1 INDICATIONS AND USAGE KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to la
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        5. context exact
          AND USAGE KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associ
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            1 INDICATIONS AND USAGE KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients.
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            apy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B 12 because of the risk of progression of neurologic manifestations despi
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                                        Preserved source evidence · Not medical advice