Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074216
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Discontinued | None | No | No |
NAPROXEN | NAPROXEN | 500MG | 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 |
---|---|---|---|---|---|---|---|
04/11/1996 | ORIG-1 | Approval |
Label is not available on this site. |