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Application 063076
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | Yes |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-1319 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-1319 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-1319 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-1319 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-5017 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-5017 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-5017 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-5017 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6509 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Hospira, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39405 | SUPPL | 2014-02-03 |