Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074242
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/07/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |