Application 078314
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET;ORAL | EQ 250MG BASE | No | No |
| 002 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET;ORAL | EQ 500MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-063 | Naproxen Sodium | Naproxen Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-275 | Naproxen Sodium | Naproxen Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-276 | Naproxen Sodium | Naproxen Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 45865-519 | Naproxen Sodium | Naproxen Sodium | Medsource Pharmaceuticals | ANDA | Current |
| 45865-519 | Naproxen Sodium | Naproxen Sodium | Medsource Pharmaceuticals | ANDA | Current |
| 55289-467 | Naproxen Sodium | Naproxen Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-183 | ANAPROX | NAPROXEN SODIUM | DIRECT RX | ANDA | Current |
| 61919-183 | ANAPROX | NAPROXEN SODIUM | DIRECT RX | ANDA | Current |
| 63629-3638 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-3638 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63874-339 | Naproxen Sodium | Naproxen Sodium | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 63874-489 | Naproxen Sodium | Naproxen Sodium | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3054 | Naproxen Sodium | Naproxen Sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-178 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68462-179 | Naproxen Sodium | Naproxen Sodium | Glenmark Pharmaceuticals Limited Inc., USA | ANDA | Current |
| 68788-6934 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6934 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6934 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0409 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23901 | ORIG | 2007-05-08 |