Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074162
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 12/21/1993 | 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 |
|---|---|---|---|---|---|
| 04/19/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/08/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/04/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/26/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/04/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/04/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/10/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/04/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |