Application 212199
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
|---|
| 50228-432 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-432 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-432 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-433 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-433 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-433 | Naproxen Sodium | Naproxen Sodium | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 63629-8516 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8516 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8516 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8517 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8517 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8517 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 68071-2333 | Naproxen Sodium | Naproxen Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7800 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7800 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2863 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2863 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2863 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70934-936 | Naproxen Sodium | Naproxen Sodium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-631 | Naproxen Sodium | Naproxen Sodium | Proficient Rx LP | ANDA | Current |
| 71205-631 | Naproxen Sodium | Naproxen Sodium | Proficient Rx LP | ANDA | Current |
| 72189-332 | Naproxen Sodium | Naproxen Sodium | Direct Rx | ANDA | Current |