Drugs@FDA: FDA-Approved Drugs
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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/29/2020 | SUPPL-1 | Labeling-Container/Carton Labels |
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 |