Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202524
Company: ROUSES POINT PHARMS
Company: ROUSES POINT PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
08/27/2012 | ORIG-1 | Approval |
Label is not available on this site. |