Application 205962
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN | AuroMedics Pharma LLC | ANDA | Current |
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN | AuroMedics Pharma LLC | ANDA | Current |
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN | AuroMedics Pharma LLC | ANDA | Current |
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN | AuroMedics Pharma LLC | ANDA | Current |
| 55150-210 | BIVALIRUDIN | BIVALIRUDIN | AuroMedics Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32770 | ORIG | 2015-12-31 |