Application 078486
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 43598-494 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-494 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-494 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-495 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-495 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-495 | Naproxen sodium | Naproxen sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 50090-5238 | Naproxen sodium | Naproxen sodium | A-S Medication Solutions | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-625 | Naproxen sodium | Naproxen sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 70518-0178 | Naproxen sodium | Naproxen sodium | REMEDYREPACK INC. | ANDA | Current |
| 71335-1650 | Naproxen sodium | Naproxen sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1650 | Naproxen sodium | Naproxen sodium | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 23910 | ORIG | 2007-08-16 |