Application 061667
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 500MG BASE/6ML | No | No |
| 002 | VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62559-830 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-830 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 63629-1970 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1970 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1970 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1970 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1970 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1971 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1971 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1971 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1971 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1972 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1972 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1972 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1972 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |