Application 062663
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | Yes |
| 003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | Yes |
| 004 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | Yes |
| 005 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 750MG BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-203 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-203 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-203 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-203 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-203 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-203 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-221 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-284 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-295 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-314 | Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |