| 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 | 204125 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2015/12/28 | 2015/12/28 | XELLIA PHARMS APS | Prescription |
| VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | 091532 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 100GM BASE | No | No | 2016/01/06 | 2016/01/06 | SAMSON MEDCL | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205694 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2016/01/21 | 2016/01/21 | GLAND PHARMA LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205694 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2016/01/21 | 2016/01/21 | GLAND PHARMA LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205694 | 003 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No | 2016/01/21 | 2023/06/06 | GLAND PHARMA LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205694 | 004 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2016/01/21 | 2023/06/06 | GLAND PHARMA LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205779 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No | 2016/03/29 | 2016/03/29 | EUGIA PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205779 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2016/03/29 | 2016/03/29 | EUGIA PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205780 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2016/03/31 | 2016/03/31 | EUGIA PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 205780 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 2016/03/31 | 2016/03/31 | EUGIA PHARMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 209481 | 001 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2018/07/10 | 2018/07/10 | MYLAN LABS LTD | Discontinued |
| VANCOMYCIN HYDROCHLORIDE | 209481 | 002 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | Yes | Yes | 2018/07/10 | 2018/07/10 | MYLAN LABS LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 209481 | 003 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.25GM BASE/VIAL | Yes | Yes | 2018/07/10 | 2018/07/10 | MYLAN LABS LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 209481 | 004 | NDA | VANCOMYCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 1.5GM BASE/VIAL | Yes | Yes | 2018/07/10 | 2018/07/10 | MYLAN LABS LTD | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 206616 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 750MG BASE/VIAL | No | No | 2018/10/03 | 2018/10/03 | HIKMA PHARMS | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 204360 | 001 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No | 2018/10/15 | 2018/10/15 | HIKMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 204360 | 002 | ANDA | VANCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No | 2018/10/15 | 2018/10/15 | HIKMA | Prescription |
| VANCOMYCIN HYDROCHLORIDE | 211962 | 001 | NDA | VANCOMYCIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | Yes | Yes | 2019/02/15 | 2019/02/15 | XELLIA PHARMS APS | Prescription |
| 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 |