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LABELS · 628f9609-6583-49be-be77-b64cfbc46fd7

Marinol

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
2019-04-08
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS & USAGE MARINOL is 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. MARINOL 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.
Full extracted label fields
application numbers
  1. NDA018651
boxed warning exact
    brand names
    1. Marinol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=628f9609-6583-49be-be77-b64cfbc46fd7
    generic names
    1. DRONABINOL
    id
    628f9609-6583-49be-be77-b64cfbc46fd7
    indications and usage exact
    1. 1 INDICATIONS & USAGE MARINOL is 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. MARINOL 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.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. ThePharmaNetwork, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 53097-568-60
      2. 53097-569-60
      3. 53097-570-60
      product ndcs
      1. 53097-568
      2. 53097-569
      3. 53097-570
      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
        4. 205641
        5. 205642
        6. 205645
        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
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22628f9609-6583-49be-be77-b64cfbc46fd7%22
        spl effective date
        2019-04-08
        spl effective time
        20190408
        spl set id
        628f9609-6583-49be-be77-b64cfbc46fd7
        spl version
        1
        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. fda_label_posted_after_spl_effective_date_requires_version_review
        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
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            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
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            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
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            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
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          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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        1 INDICATIONS & USAGE MARINOL is 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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            1 INDICATIONS & USAGE MARINOL is indicated in adults for the treatment of:
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            biomarker and test
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            tumor histology
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                  • anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS).
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                  1 INDICATIONS & USAGE MARINOL is 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. MARINOL 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 patie
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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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                        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. MARINOL 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 antiemeti
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                            omiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. MARINOL 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.
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                                  • Anorexia associated with weight loss in patients with AIDS.
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                                  ve failed to respond adequately to conventional antiemetic treatments. MARINOL 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.
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                                        ailed to respond adequately to conventional antiemetic treatments. MARINOL 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.
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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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                                              Preserved source evidence · Not medical advice