Application 215197
- Type
- ANDA
- Sponsor
- NANJING KING-FRIEND
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 | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71288-022 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-023 | Vancomycin Hydrochloride | Vancomycin Hydrochloride | Meitheal Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71685 | ORIG | 2022-08-01 |