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LABELS · f9804c15-4d58-415f-be1b-28fd387774bd

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
2026-05-13
Captured
2026-09-09T23:38:04.335995+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=fd8c5d57-0173-4f62-8ff0-d8147986a976
    generic names
    1. DRONABINOL
    id
    f9804c15-4d58-415f-be1b-28fd387774bd
    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
        manufacturer names
        1. Major Pharmaceuticals
        matched search terms
        1. cancer
        package ndcs
        1. 0904-7144-61
        2. 0904-7145-04
        product ndcs
        1. 0904-7144
        2. 0904-7145
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. ORAL
          rxcuis
          1. 197635
          2. 197636
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00800.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
          800
          total
          830
          sha256
          8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
          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=800&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22f9804c15-4d58-415f-be1b-28fd387774bd%22
          spl effective date
          2026-05-13
          spl effective time
          20260513
          spl set id
          fd8c5d57-0173-4f62-8ff0-d8147986a976
          spl version
          6
          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
          4. not_identified_as_original_packager
          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
          1. NDA018651
          brand names
          1. Dronabinol
          classification reasons
          1. explicit_positive_indication_predicate
          2. no_tumor_directed_keyword_in_positive_statement
          clinical review status
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          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 ad
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            INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of:
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              1 INDICATIONS AND USAGE Dronabinol capsules are indicated in adults for the treatment of:
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              Source null
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              biomarker and test
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              Source null
              limitations
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              regimen
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              tumor histology
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              use intent
              non_oncology_or_unclear_candidate
              Passage 2 · positive indication candidate
              application numbers
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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. Dronabinol capsules is a cannabinoid indicated in ad
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                    • anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS).
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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. 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 chemoth
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                          • 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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                          Source null
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                          application numbers
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                          classification reasons
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                          nts 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 antieme
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                                                      Preserved source evidence · Not medical advice