Application 201577
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 55111-652 | Bivalirudin | Bivalirudin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-652 | Bivalirudin | Bivalirudin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-652 | Bivalirudin | Bivalirudin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-652 | Bivalirudin | Bivalirudin | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48604 | ORIG | 2017-05-31 |