Application 075474
- Type
- ANDA
- Sponsor
- FRONTIDA BIOPHARM
Related Records
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 | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52817-270 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 52817-270 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 52817-270 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 52817-271 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 52817-271 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 52817-271 | Bisoprolol | Bisoprolol fumarate | TruPharma, LLC | ANDA | Current |
| 63629-6907 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6907 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6907 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6907 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 68071-5097 | Bisoprolol | Bisoprolol fumarate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5097 | Bisoprolol | Bisoprolol fumarate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-1678 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1678 | Bisoprolol | Bisoprolol fumarate | Bryant Ranch Prepack | ANDA | Current |