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LABELS · 7b8f0ddb-00fd-4c22-afae-afe636f95f3a

Aminocaproic Acid

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
2024-01-08
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings . )
Full extracted label fields
application numbers
  1. NDA015230
  2. NDA015197
boxed warning exact
    brand names
    1. Aminocaproic Acid
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b8f0ddb-00fd-4c22-afae-afe636f95f3a
    generic names
    1. AMINOCAPROIC ACID
    id
    7b8f0ddb-00fd-4c22-afae-afe636f95f3a
    indications and usage exact
    1. INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings . )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Hikma Pharmaceuticals USA Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 0054-1110-13
      2. 0054-1100-58
      product ndcs
      1. 0054-1100
      2. 0054-1110
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 476271
        2. 582299
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%227b8f0ddb-00fd-4c22-afae-afe636f95f3a%22
        spl effective date
        2024-01-08
        spl effective time
        20240108
        spl set id
        7b8f0ddb-00fd-4c22-afae-afe636f95f3a
        spl version
        1
        substance names
        1. AMINOCAPROIC ACID
        uniis
        1. U6F3787206
        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
          NDA015197
          payload
          all indexed label documents
          1. Appl No
            015197
            Application Docs Date
            2004-06-25 00:00:00
            Application Docs ID
            10855
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            38
            Submission Type
            SUPPL
          2. Appl No
            015197
            Application Docs Date
            2008-08-26 00:00:00
            Application Docs ID
            10856
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            43
            Submission Type
            SUPPL
          3. Appl No
            015197
            Application Docs Date
            2004-06-25 00:00:00
            Application Docs ID
            33131
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          4. Appl No
            015197
            Application Docs Date
            2004-06-25 00:00:00
            Application Docs ID
            33132
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            37
            Submission Type
            SUPPL
          5. Appl No
            015197
            Application Docs Date
            2004-06-25 00:00:00
            Application Docs ID
            33133
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            39
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1964-06-03 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            1977-02-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            1981-06-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            1982-10-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            015197
            Review Priority
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            1990-04-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            1982-09-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            015197
            Review Priority
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            1982-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            015197
            Review Priority
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            1983-06-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            015197
            Review Priority
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            1986-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            1992-08-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            015197
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            1992-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            015197
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            1997-04-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA015197
          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
          2008-08-19
          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
            015197
            Application Docs Date
            2008-08-26 00:00:00
            Application Docs ID
            10856
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            43
            Submission Type
            SUPPL
          official application record
          Appl No
          015197
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          HIKMA
          openfda application present
          true
          products
          1. Active Ingredient
            AMINOCAPROIC ACID
            Appl No
            015197
            Drug Name
            AMICAR
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            500MG
            marketing status
            1. Prescription
          2. Active Ingredient
            AMINOCAPROIC ACID
            Appl No
            015197
            Drug Name
            AMICAR
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            1GM
            marketing status
            1. Prescription
        2. application number
          NDA015230
          payload
          all indexed label documents
          1. Appl No
            015230
            Application Docs Date
            2008-08-26 00:00:00
            Application Docs ID
            10857
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            35
            Submission Type
            SUPPL
          2. Appl No
            015230
            Application Docs Date
            2009-02-04 00:00:00
            Application Docs ID
            10858
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            37
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            015230
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            37
            Submission Status
            AP
            Submission Status Date
            2009-02-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            015230
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            35
            Submission Status
            AP
            Submission Status Date
            2008-08-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            015230
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            2004-08-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            2003-09-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2003-09-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2003-09-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            1999-09-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            1999-09-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            1999-09-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            1997-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            015230
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            1997-04-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            015230
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            1986-11-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA015230
          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
          2009-02-03
          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
            015230
            Application Docs Date
            2009-02-04 00:00:00
            Application Docs ID
            10858
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            37
            Submission Type
            SUPPL
          official application record
          Appl No
          015230
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          HIKMA
          openfda application present
          true
          products
          1. Active Ingredient
            AMINOCAPROIC ACID
            Appl No
            015230
            Drug Name
            AMICAR
            Form
            SOLUTION;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.25GM/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 · unclassified context
        application numbers
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        2. NDA015197
        brand names
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        clinical review status
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        exact text
        INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications
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        positive predicate support span
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        qualifier mentions
          regulatory links
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              INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding.
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              biomarker and test
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              Source null
              prior therapy
              Source null
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              Source null
              tumor histology
              Source null
              use intent
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              Passage 2 · unclassified context
              application numbers
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              2. NDA015197
              brand names
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              INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such a
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              positive predicate support span
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                regulatory links
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                    In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
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                    source url
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                    spl effective date
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                    Source null
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                    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. NDA015230
                    2. NDA015197
                    brand names
                    1. Aminocaproic Acid
                    classification reasons
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                    clinical review status
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                    true
                    exact text
                    id is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephre
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                    offset unit
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                        Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
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