Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074635
Company: CONTRACT PHARMACAL
Company: CONTRACT PHARMACAL
| 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 |
|---|---|---|---|---|---|
| 03/13/2006 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/04/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1999 | 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 |