Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074495
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 |
|---|---|---|---|---|---|---|---|
| 12/05/1994 | 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 |
|---|---|---|---|---|---|
| 08/28/2025 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/28/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/28/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/04/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/27/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/27/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/29/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |