商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | 215196 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2022/07/27 | 2022/07/27 | MEITHEAL | Prescription |
VANCOMYCIN HYDROCHLORIDE | 215197 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2022/07/28 | 2022/07/28 | MEITHEAL | Prescription |
VANCOMYCIN HYDROCHLORIDE | 215197 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2022/07/28 | 2022/07/28 | MEITHEAL | Prescription |
VANCOMYCIN HYDROCHLORIDE | 215195 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 750MG BASE/VIAL | No | No | 2022/09/15 | 2022/09/15 | MEITHEAL | Prescription |
VANCOMYCIN HYDROCHLORIDE | 214913 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 25MG BASE/ML | No | No | 2022/11/14 | 2022/11/14 | ALKEM LABS LTD | Prescription |
VANCOMYCIN HYDROCHLORIDE | 214913 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 50MG BASE/ML | No | No | 2022/11/14 | 2022/11/14 | ALKEM LABS LTD | Prescription |
VANCOMYCIN HYDROCHLORIDE | 210274 | 001 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 500MG BASE/VIAL | Yes | Yes | 2023/01/20 | 2023/01/20 | ZHEJIANG NOVUS PHARM | Prescription |
VANCOMYCIN HYDROCHLORIDE | 210274 | 002 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 1GM BASE/VIAL | Yes | Yes | 2023/01/20 | 2023/01/20 | ZHEJIANG NOVUS PHARM | Prescription |
VANCOMYCIN HYDROCHLORIDE | 210274 | 003 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 5GM BASE/VIAL | Yes | Yes | 2023/01/20 | 2023/01/20 | ZHEJIANG NOVUS PHARM | Prescription |
VANCOMYCIN HYDROCHLORIDE | 210274 | 004 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS, ORAL | EQ 10GM BASE/VIAL | Yes | Yes | 2023/01/20 | 2023/01/20 | ZHEJIANG NOVUS PHARM | Prescription |
VANCOMYCIN HYDROCHLORIDE | 215338 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | No | No | 2023/06/23 | 2023/06/23 | AMNEAL | Prescription |
VANCOMYCIN HYDROCHLORIDE | 217489 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.25GM BASE/VIAL | No | No | 2023/06/29 | 2023/06/29 | HIKMA | Prescription |
VANCOMYCIN HYDROCHLORIDE | 217489 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.5GM BASE/VIAL | No | No | 2023/06/29 | 2023/06/29 | HIKMA | Prescription |
VANCOMYCIN HYDROCHLORIDE | 217401 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.25GM BASE/VIAL | No | No | 2023/08/04 | 2023/08/04 | EUGIA PHARMA | Prescription |
VANCOMYCIN HYDROCHLORIDE | 217401 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.5GM BASE/VIAL | No | No | 2023/08/04 | 2023/08/04 | EUGIA PHARMA | Prescription |