Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG 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 |
|---|---|---|---|---|---|---|---|
| 05/14/1996 | 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 |
|---|---|---|---|---|---|
| 09/08/2008 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 05/08/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/16/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 10/05/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/07/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 06/09/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/09/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/01/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-6 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 03/14/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/06/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |