Application 210955
- Type
- ANDA
- Sponsor
- BEXIMCO PHARMS USA
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NADOLOL | NADOLOL | TABLET;ORAL | 20MG | No | No |
| 002 | NADOLOL | NADOLOL | TABLET;ORAL | 40MG | No | No |
| 003 | NADOLOL | NADOLOL | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10135-686 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-686 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-686 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-687 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-687 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-687 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-688 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-688 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-688 | Nadolol | Nadolol | Marlex Pharmaceuticals Inc | ANDA | Current |
| 71335-2131 | Nadolol | Nadolol | Bryant Ranch Prepack | ANDA | Current |
| 76385-133 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-133 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-134 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-134 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-135 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-135 | Nadolol | Nadolol | Bayshore Pharmaceuticals LLC | ANDA | Current |
Documents
No records found.