Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214918
Company: LUPIN LTD
Company: LUPIN LTD
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 |
---|---|---|---|---|---|---|---|
12/20/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214918Orig1s000TA_ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |