Application 210031
- Type
- ANDA
- Sponsor
- SHUANGCHENG
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 |
|---|---|---|---|---|---|
| 52958-034 | Bivalirudin | Bivalirudin | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | ANDA | Current |
| 52958-034 | Bivalirudin | Bivalirudin | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | ANDA | Current |
| 70860-402 | Bivalirudin | bivalirudin | Athenex Pharmaceutical Division, LLC. | ANDA | Current |