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LABELS · dcc02ae3-f1fa-431e-81bb-c52d35b81c66

SYNDROS

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
2026-04-17
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SYNDROS 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. SYNDROS 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. NDA205525
boxed warning exact
    brand names
    1. SYNDROS
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89
    generic names
    1. DRONABINOL
    id
    dcc02ae3-f1fa-431e-81bb-c52d35b81c66
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SYNDROS 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. SYNDROS 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. Wellhouse Pharma, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 85776-201-30
      product ndcs
      1. 85776-201
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1928948
        2. 1928954
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00700.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
        700
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2026-04-17
        spl effective time
        20260417
        spl set id
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        spl version
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        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
          NDA205525
          payload
          all indexed label documents
          1. Appl No
            205525
            Application Docs Date
            2016-07-05 00:00:00
            Application Docs ID
            46984
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            205525
            Application Docs Date
            2017-06-06 00:00:00
            Application Docs ID
            48661
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            205525
            Application Docs Date
            2018-09-18 00:00:00
            Application Docs ID
            55495
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          4. Appl No
            205525
            Application Docs Date
            2021-07-06 00:00:00
            Application Docs ID
            68014
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          5. Appl No
            205525
            Application Docs Date
            2022-09-23 00:00:00
            Application Docs ID
            72141
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          6. Appl No
            205525
            Application Docs Date
            2024-05-20 00:00:00
            Application Docs ID
            78517
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2016-07-01 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
            FR Notice on DEA Scheduling; Date of Approval – March 23, 2017
          2. Appl No
            205525
            Review Priority
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2016-12-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2017-05-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2018-04-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2018-09-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2021-03-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2022-09-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            205525
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2024-05-17 00:00:00
            Submission Type
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            Submissions Public Notes
          application number
          NDA205525
          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
          2024-05-17
          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
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            Application Docs Date
            2024-05-20 00:00:00
            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            13
            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          WELLHOUSE PHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            DRONABINOL
            Appl No
            205525
            Drug Name
            SYNDROS
            Form
            SOLUTION;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
            marketing status
            1. Discontinued

        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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        2. supportive_or_complication_use_words
        clinical review status
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        true
        exact text
        1 INDICATIONS AND USAGE SYNDROS 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. SYNDROS 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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          1 INDICATIONS AND USAGE SYNDROS is indicated in adults for the treatment of: anorexia associated with weight loss
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            1 INDICATIONS AND USAGE SYNDROS 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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            tumor histology
            Source null
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            Passage 2 · positive indication candidate
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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. SYNDROS 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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                have failed to respond adequately to conventional antiemetic treatments. SYNDROS 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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                      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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                            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