Drugs@FDA: FDA-Approved Drugs
Company: NORVIUM BIOSCIENCE
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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
03/19/2020 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2020 | SUPPL-23 | Labeling-Medication Guide |
Label is not available on this site. |
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03/19/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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07/25/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
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06/07/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/01/1999 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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04/22/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/04/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/16/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/15/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/23/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |