Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091305
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 08/24/2011 | 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 |
|---|---|---|---|---|---|
| 10/25/2019 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |