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Application 090816
- Type
- ANDA
- Sponsor
- HOSPIRA INC
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 |
|---|
| 0409-8300 | Bivalirudin | BIVALIRUDIN | Hospira, Inc. | ANDA | Current |
| 0409-8300 | Bivalirudin | BIVALIRUDIN | Hospira, Inc. | ANDA | Current |
| 0409-8300 | Bivalirudin | BIVALIRUDIN | Hospira, Inc. | ANDA | Current |
| 0409-8300 | Bivalirudin | BIVALIRUDIN | Hospira, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39612 | ORIG | 2015-07-16 |
| 31498 | ORIG | 2015-07-15 |