Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074289
Company: TEVA PHARMS
Company: TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 01/27/1994 | 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 |
|---|---|---|---|---|---|
| 03/29/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/29/2021 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |