Drugs@FDA: FDA-Approved Drugs
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
01/13/1997 | 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 |
---|---|---|---|---|---|
10/25/2014 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2014 | SUPPL-58 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/25/2014 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2012 | SUPPL-44 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/07/2010 | SUPPL-43 | Labeling |
Label is not available on this site. |
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11/12/2014 | SUPPL-40 | Labeling |
Label is not available on this site. |
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12/19/2006 | SUPPL-28 | Labeling |
Label is not available on this site. |
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03/13/2006 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/20/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/20/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/10/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/25/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/19/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
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08/28/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/11/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NAPROXEN SODIUM
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 220MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ALEVE | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | Yes | 020204 | BAYER |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 079096 | AMNEAL PHARMS NY |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 205497 | AUROBINDO PHARMA LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 074635 | CONTRACT PHARMACAL |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 075168 | DR REDDYS LABS INC |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 091353 | GRANULES INDIA |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 211065 | HETERO LABS LTD V |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 204872 | LNK INTL INC |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 090545 | MARKSANS PHARMA |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 207612 | NOVELGENIX THERAPS |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 074661 | PERRIGO |
NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 212033 | YICHANG HUMANWELL |