Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 212033
Company: YICHANG HUMANWELL
Company: YICHANG HUMANWELL
| 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2019 | ORIG-1 | Approval | STANDARD |
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 | 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 | 091183 | SUN PHARM INDS LTD |
| NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET;ORAL | Over-the-counter | No | 212033 | YICHANG HUMANWELL |
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