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-61（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-55（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-43（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/04/13 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/05/08 |
SUPPL-42（补充） |
Approval |
Labeling |
|
|
|
| 2011/11/30 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/18 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2008/08/21 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 2002/10/04 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/02/01 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/06/14 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/07/14 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/09 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/11/13 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/10/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/07/23 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/05 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/05 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/08/04 |
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 500MG 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 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1987/03/17
|
FRESENIUS KABI USA |
| 062911 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1988/08/04
|
HOSPIRA |
| 062931 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1992/10/29
|
HOSPIRA |
| 065401 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2008/06/30
|
MEDIMETRIKS PHARMS |
| 065397 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2008/12/30
|
MYLAN LABS LTD |
| 090250 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2010/04/27
|
SANDOZ |
| 204107 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2015/12/28
|
HIKMA |
| 205694 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/01/21
|
GLAND PHARMA LTD |
| 205780 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/03/31
|
EUGIA PHARMA |
| 212332 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/06/12
|
SLATE RUN PHARMA |
| 213059 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2022/02/15
|
KNACK |
| 216591 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/07/06
|
ASPIRO |
| 215197 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
VANCOMYCIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/07/28
|
MEITHEAL |
