Application 074480
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET;ORAL | EQ 500MG BASE | No | No |
| 002 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET;ORAL | EQ 250MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9908 | NAPROXEN | naproxen sodium | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9916 | NAPROXEN | naproxen sodium | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 10544-614 | NAPROXEN | naproxen sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 59115-002 | Naproxen Sodium | Naproxen Sodium | Hikma Pharmaceutical | ANDA | Current |
| 59115-002 | Naproxen Sodium | Naproxen Sodium | Hikma Pharmaceutical | ANDA | Current |