批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2021/05/24 |
SUPPL-50（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-38（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/11/03 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 2012/06/12 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2011/11/30 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 2009/05/27 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 2002/03/15 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/02/01 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/06/14 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/09 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/04/04 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/11/18 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/25 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/05/10 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/04/09 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/10/29 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 062663 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
1987/07/31
|
FRESENIUS KABI USA |
| 062912 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
1988/08/04
|
HOSPIRA |
| 062933 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
1992/10/29
|
HOSPIRA |
| 065401 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2008/06/30
|
PHARM ASSOC |
| 065397 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2008/12/30
|
MYLAN LABS LTD |
| 090250 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2010/04/27
|
SANDOZ |
| 204107 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2015/12/28
|
XELLIA PHARMS APS |
| 205694 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2016/01/21
|
GLAND PHARMA LTD |
| 205780 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2016/03/31
|
EUGIA PHARMA |
| 212332 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2019/06/12
|
HAINAN POLY PHARM |
| 203300 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2020/08/11
|
HIKMA |
| 213059 |
003 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2022/02/15
|
KNACK |
| 216591 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2022/07/06
|
ASPIRO |
| 215197 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2022/07/28
|
MEITHEAL |
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 750MG BASE/VIAL 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 062912 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Prescription |
No |
No |
AP |
2009/01/07
|
HOSPIRA |
| 062933 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Prescription |
No |
No |
AP |
2009/05/27
|
HOSPIRA |
| 062663 |
005 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/08/17
|
FRESENIUS KABI USA |
| 206616 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Prescription |
No |
No |
AP |
2018/10/03
|
HIKMA PHARMS |
| 213059 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2022/02/15
|
KNACK |
| 215195 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 750MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/09/15
|
MEITHEAL |
