Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076494
Company: HIKMA INTL PHARMS
Company: HIKMA INTL 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2004 | 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 |
|---|---|---|---|---|---|
| 11/26/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/26/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/26/2019 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/16/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/08/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |