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LABELS · 97b6c4dc-59b5-4ee6-b296-26ccdf9ef853

Dronabinol

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
2026-05-06
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
Full extracted label fields
application numbers
  1. NDA018651
boxed warning exact
    brand names
    1. Dronabinol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adb1801c-0fb5-4e16-b969-1db91230e0b9
    generic names
    1. DRONABINOL
    id
    97b6c4dc-59b5-4ee6-b296-26ccdf9ef853
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Ascend Laboratories, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 67877-753-60
      2. 67877-754-60
      3. 67877-755-60
      product ndcs
      1. 67877-753
      2. 67877-754
      3. 67877-755
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 197634
        2. 197635
        3. 197636
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        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=500&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2297b6c4dc-59b5-4ee6-b296-26ccdf9ef853%22
        spl effective date
        2026-05-06
        spl effective time
        20260506
        spl set id
        adb1801c-0fb5-4e16-b969-1db91230e0b9
        spl version
        5
        substance names
        1. DRONABINOL
        uniis
        1. 7J8897W37S
        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
          NDA018651
          payload
          all indexed label documents
          1. Appl No
            018651
            Application Docs Date
            2003-05-06 00:00:00
            Application Docs ID
            11258
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          2. Appl No
            018651
            Application Docs Date
            2005-04-28 00:00:00
            Application Docs ID
            11259
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          3. Appl No
            018651
            Application Docs Date
            2006-06-28 00:00:00
            Application Docs ID
            11260
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          4. Appl No
            018651
            Application Docs Date
            2006-06-28 00:00:00
            Application Docs ID
            33540
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            25
            Submission Type
            SUPPL
          5. Appl No
            018651
            Application Docs Date
            2000-09-22 00:00:00
            Application Docs ID
            45040
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          6. Appl No
            018651
            Application Docs Date
            2017-08-30 00:00:00
            Application Docs ID
            49585
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          7. Appl No
            018651
            Application Docs Date
            2023-01-18 00:00:00
            Application Docs ID
            73247
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            33
            Submission Type
            SUPPL
          8. Appl No
            018651
            Application Docs Date
            2026-03-27 00:00:00
            Application Docs ID
            85542
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2026-03-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            2023-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2017-08-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2006-06-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2006-06-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2005-04-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            018651
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2004-05-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            018651
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2003-04-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            018651
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2002-09-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            018651
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2002-09-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            018651
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2002-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            018651
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2001-04-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA018651
          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
          2026-03-25
          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
            018651
            Application Docs Date
            2026-03-27 00:00:00
            Application Docs ID
            85542
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          official application record
          Appl No
          018651
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ALKEM LABS LTD
          openfda application present
          true
          products
          1. Active Ingredient
            DRONABINOL
            Appl No
            018651
            Drug Name
            MARINOL
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            2.5MG
            marketing status
            1. Prescription
          2. Active Ingredient
            DRONABINOL
            Appl No
            018651
            Drug Name
            MARINOL
            Form
            CAPSULE;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            5MG
            marketing status
            1. Prescription
          3. Active Ingredient
            DRONABINOL
            Appl No
            018651
            Drug Name
            MARINOL
            Form
            CAPSULE;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            10MG
            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
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        brand names
        1. Dronabinol
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
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        content role
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        context span
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        532
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        true
        exact text
        1 INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherap
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        qualifier mentions
        1. context exact
          INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss
          kind
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            1 INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            structured indication
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            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
            supportive_care_candidate
            Passage 2 · positive indication candidate
            application numbers
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            brand names
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            classification reasons
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            ients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
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            qualifier mentions
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              kind
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                Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS.
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                to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
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                      ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
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                      disease stage
                      Source null
                      limitations
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                      Source null
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                      regimen
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                      tumor histology
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                      Passage 4 · unclassified context
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                      sociated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
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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

                            Preserved source evidence · Not medical advice