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-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/28 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/28 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/04/29 |
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 10GM 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 |
004 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
1997/11/28
|
FRESENIUS KABI USA |
| 065455 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2009/04/29
|
HOSPIRA INC |
| 091554 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
2011/09/19
|
MYLAN LABS LTD |
| 201048 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2012/08/10
|
SANDOZ INC |
| 200837 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2014/09/02
|
SAGENT PHARMS |
| 204125 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2015/12/28
|
XELLIA PHARMS APS |
| 205779 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2016/03/29
|
EUGIA PHARMA |
| 204360 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2018/10/15
|
HIKMA |
| 063076 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2020/09/14
|
HOSPIRA |
| 215821 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2021/11/18
|
SLATE RUN PHARMA |
| 215196 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2022/07/27
|
MEITHEAL |
| 205694 |
004 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 10GM BASE/VIAL |
Prescription |
No |
No |
AP |
2023/06/06
|
GLAND PHARMA LTD |