Application 210274
- Type
- NDA
- Sponsor
- ZHEJAING NOVUS PHARMACEUTICALS CO. LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
| 002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 1GRAM/VIAL | No | No |
| 003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 5GRAM/VIAL | No | No |
| 004 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10GRAM/VIAL | No | No |
| 005 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 750MG BASE/VIAL | Yes | Yes |
| 006 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 1.25GM BASE/VIAL | Yes | Yes |
| 007 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 1.5MG BASE/VIAL | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82458 | SUPPL | 2025-06-04 |
| 82363 | SUPPL | 2025-05-30 |
| 77041 | ORIG | 2023-12-19 |
| 73279 | ORIG | 2023-01-24 |
| 73275 | ORIG | 2023-01-23 |