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LABELS · 5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48

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
2023-02-14
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 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. ( 1 )
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=d0efeeec-640d-43c3-8f0a-d31324a11c68
    generic names
    1. DRONABINOL
    id
    5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
    indications and usage exact
    1. 1 INDICATIONS AND 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. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. ThePharmaNetwork, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 53097-571-60
      2. 53097-572-60
      3. 53097-573-60
      product ndcs
      1. 53097-571
      2. 53097-572
      3. 53097-573
      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-00300.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
        300
        total
        830
        sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        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=300&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%225ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48%22
        spl effective date
        2023-02-14
        spl effective time
        20230214
        spl set id
        d0efeeec-640d-43c3-8f0a-d31324a11c68
        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
        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
            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. MARINOL
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
        pending
        content role
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        context span
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        519
        end exclusive
        true
        exact text
        1 INDICATIONS AND 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 patient
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss
          kind
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            1 INDICATIONS AND 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.
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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
            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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            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. 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. ( 1 )
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            positive predicate support span
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              MARINOL is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss
              kind
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                MARINOL is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS.
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                non_oncology_or_unclear_candidate
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                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. ( 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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                      source url
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                      Passage 4 · unclassified context
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                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      603
                      end exclusive
                      true
                      exact text
                      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 )
                      label id
                      5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      c7a074ba1fd70886aef3b27ad1ae415f8d0b79411976057ca6f6831b30e7a595
                      start
                      398
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-78ae0422abd24c3e7b45
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. DRONABINOL
                      id
                      ind-span-c1430857448371a2f6cc
                      label id
                      5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                          source defined aliases
                            source span
                            end
                            603
                            end exclusive
                            true
                            exact text
                            ( 1 )
                            label id
                            5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            c7a074ba1fd70886aef3b27ad1ae415f8d0b79411976057ca6f6831b30e7a595
                            start
                            598
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%225ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48%22
                            spl effective date
                            2023-02-14
                            spl set id
                            d0efeeec-640d-43c3-8f0a-d31324a11c68
                            spl version
                            5
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            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
                            unclear

                            Preserved source evidence · Not medical advice