Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214501
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/03/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214501Orig1s000TAltr.pdf |