Application 091602
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BIVALIRUDIN | BIVALIRUDIN | INJECTABLE;INTRAVENOUS | 250MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-405 | bivalirudin | bivalirudin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-405 | bivalirudin | bivalirudin | Sagent Pharmaceuticals | ANDA | Current |
| 69097-601 | bivalirudin | bivalirudin | Cipla USA Inc. | ANDA | Current |
| 69097-601 | bivalirudin | bivalirudin | Cipla USA Inc. | ANDA | Current |
| 71288-427 | BIVALIRUDIN | BIVALIRUDIN | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-427 | BIVALIRUDIN | BIVALIRUDIN | Meitheal Pharmaceuticals Inc. | ANDA | Current |