Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215663
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/15/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/30/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |