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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205525
Company: BENUVIA OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNDROS DRONABINOL 5MG/ML SOLUTION;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
07/01/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Federal Register Notice
Label (PDF)
Letter (PDF)
Review
FR Notice on DEA Scheduling; Date of Approval – March 23, 2017
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
05/17/2024 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
09/21/2022 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
03/22/2021 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
09/14/2018 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
04/12/2018 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

05/25/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
12/08/2016 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
05/17/2024 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
09/21/2022 SUPPL-11 Labeling-Patient Package Insert Label (PDF)
09/21/2022 SUPPL-11 Labeling-Package Insert Label (PDF)
03/22/2021 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
03/22/2021 SUPPL-9 Labeling-Package Insert Label (PDF)
09/14/2018 SUPPL-7 Labeling-Package Insert Label (PDF)
05/25/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
07/01/2016 ORIG-1 Approval Label (PDF)
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