Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076306
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
TOPIRAMATE | TOPIRAMATE | 200MG | 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 |
---|---|---|---|---|---|---|---|
09/08/2003 | ORIG-1 | Tentative Approval |
Label is not available on this site. |