Application 075643
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
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 |
| 003 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET;ORAL | 2.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0185-0771 | bisoprolol fumarate | bisoprolol fumarate | Eon Labs, Inc. | ANDA | Current |
| 0185-0774 | bisoprolol fumarate | bisoprolol fumarate | Eon Labs, Inc. | ANDA | Current |
| 68084-487 | bisoprolol fumarate | bisoprolol fumarate | American Health Packaging | ANDA | Current |
| 72888-092 | Bisoprolol Fumarate | Bisoprolol Fumarate | Advagen Pharma Ltd | ANDA | Current |
| 72888-093 | Bisoprolol Fumarate | Bisoprolol Fumarate | Advagen Pharma Ltd | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30972 | ORIG | 2000-11-16 |