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Application 206551
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|
| 16729-275 | Bivalirudin | Bivalirudin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-275 | Bivalirudin | bivalirudin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-275 | Bivalirudin | bivalirudin | Accord Healthcare, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50511 | ORIG | 2017-11-27 |
| 10580 | ORIG | 2016-05-04 |