Application 207428
- Type
- ANDA
- Sponsor
- BEXIMCO PHARMS USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
| 003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10135-661 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-661 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-661 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-662 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-662 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-662 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-663 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-663 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-663 | Sotalol | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-715 | Sotalol Hydrochloride | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-716 | Sotalol Hydrochloride | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-717 | Sotalol Hydrochloride | Sotalol Hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 71335-1189 | Sotalol | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1189 | Sotalol | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-385 | Sotalol | Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76385-114 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-114 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-114 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-115 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-115 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-115 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-116 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-116 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-116 | Sotalol | Sotalol Hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |