Application 200629
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| 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 | Labeler | Marketing category | Status |
|---|
| 50090-3352 | Naproxen Sodium | Naproxen Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3352 | Naproxen Sodium | Naproxen Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3352 | Naproxen Sodium | Naproxen Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3352 | Naproxen Sodium | Naproxen Sodium | A-S Medication Solutions | ANDA | Current |
| 53002-5330 | Naproxen Sodium | Naproxen Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 65862-515 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-515 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-515 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-515 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-516 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-516 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-516 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-516 | Naproxen Sodium | Naproxen Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4901 | Naproxen Sodium | Naproxen Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4901 | Naproxen Sodium | Naproxen Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7304 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7304 | Naproxen Sodium | Naproxen Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1172 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1172 | Naproxen Sodium | Naproxen Sodium | REMEDYREPACK INC. | ANDA | Current |
| 71205-479 | Naproxen Sodium | Naproxen Sodium | Proficient Rx LP | ANDA | Current |
| 71335-0822 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0822 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0822 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1925 | Naproxen Sodium | Naproxen Sodium | Bryant Ranch Prepack | ANDA | Current |