Application 075831
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|
| 0378-0523 | Bisoprolol Fumarate | bisoprolol fumarate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0523 | Bisoprolol Fumarate | bisoprolol fumarate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0524 | Bisoprolol Fumarate | bisoprolol fumarate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0524 | Bisoprolol Fumarate | bisoprolol fumarate | Mylan Pharmaceuticals Inc. | ANDA | Current |