Application 078635
- Type
- ANDA
- Sponsor
- UNICHEM PHARMS (USA)
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET;ORAL | 5MG | No | No |
| 002 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET;ORAL | 10MG | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-667 | Bisoprolol Fumarate | Bisoprolol fumarate | Rebel Distributors Corp | ANDA | Current |
| 21695-670 | Bisoprolol Fumarate | Bisoprolol fumarate | Rebel Distributors Corp | ANDA | Current |
| 29300-126 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-126 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-126 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-126 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-127 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-127 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-127 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-127 | Bisoprolol Fumarate | Bisoprolol fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 60687-679 | Bisoprolol Fumarate | Bisoprolol fumarate | American Health Packaging | ANDA | Current |
| 61919-787 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | DIRECTRX | ANDA | Current |
| 63187-871 | Bisoprolol Fumarate | Bisoprolol fumarate | Proficient Rx LP | ANDA | Current |
| 63187-871 | Bisoprolol Fumarate | Bisoprolol fumarate | Proficient Rx LP | ANDA | Current |
| 63629-5173 | Bisoprolol Fumarate | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-5173 | Bisoprolol Fumarate | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 68071-1582 | Bisoprolol Fumarate | Bisoprolol fumarate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1582 | Bisoprolol Fumarate | Bisoprolol fumarate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1582 | Bisoprolol Fumarate | Bisoprolol fumarate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68151-4504 | Bisoprolol Fumarate | Bisoprolol fumarate | Carilion Materials Management | ANDA | Current |
| 68788-6775 | Bisoprolol Fumarate | Bisoprolol fumarate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6775 | Bisoprolol Fumarate | Bisoprolol fumarate | Preferred Pharmaceuticals, Inc. | ANDA | Current |