Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205525
Company: BENUVIA OPERATIONS
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) |