Application 214913
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 25MG BASE/ML | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 50MG BASE/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72941 | ORIG | 2022-12-20 |