| 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 | 211962 | 002 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2019/02/15 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 003 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2019/02/15 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 004 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2019/02/15 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 005 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2020/05/13 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 006 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2020/05/13 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 007 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2020/05/13 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 210729 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 125MG BASE | No | No | 2019/04/29 | 2019/04/29 | ORIENT PHARMA CO LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 210729 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 250MG BASE | No | No | 2019/04/29 | 2019/04/29 | ORIENT PHARMA CO LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 212332 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2019/06/12 | 2019/06/12 | SLATE RUN PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 212332 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2019/06/12 | 2019/06/12 | SLATE RUN PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 203300 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2020/08/11 | 2020/08/11 | HIKMA | Discontinued |
| VANCOMYCIN HYDROCHLORIDE | 203300 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2020/08/11 | 2020/08/11 | HIKMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 215821 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No | 2021/11/18 | 2021/11/18 | SLATE RUN PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 215821 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2021/11/18 | 2021/11/18 | SLATE RUN PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 213059 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2022/02/15 | 2022/02/15 | KNACK | Discontinued |
| VANCOMYCIN HYDROCHLORIDE | 213059 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 750MG BASE/VIAL | No | No | 2022/02/15 | 2022/02/15 | KNACK | Discontinued |
| VANCOMYCIN HYDROCHLORIDE | 213059 | 003 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2022/02/15 | 2022/02/15 | KNACK | Discontinued |
| VANCOMYCIN HYDROCHLORIDE | 216591 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2022/07/06 | 2022/07/06 | ASPIRO | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 216591 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2022/07/06 | 2022/07/06 | ASPIRO | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 215196 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No | 2022/07/27 | 2022/07/27 | MEITHEAL | Prescription |