Application 213078
- Type
- ANDA
- Sponsor
- HAINAN POLY PHARMACEUTICAL CO LTD
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 |
|---|---|---|---|---|---|
| 70436-025 | bivalirudin | bivalirudin | Slate Run Pharmaceuticals, LLC | ANDA | Current |