Application 076494
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN | NAPROXEN | TABLET;ORAL | 250MG | No | No |
| 002 | NAPROXEN | NAPROXEN | TABLET;ORAL | 375MG | No | No |
| 003 | NAPROXEN | NAPROXEN | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1346 | Naproxen | Naproxen | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1347 | Naproxen | Naproxen | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1348 | Naproxen | Naproxen | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 10544-061 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 43353-677 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |