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 |
|---|
| 2018/07/26 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/01/30 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 2010/11/23 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 2009/05/12 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2002/01/29 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2000/12/05 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1999/08/25 |
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:VECURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/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 |
|---|
| 074688 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
1999/08/25
|
MEITHEAL |
| 075164 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
1999/10/21
|
HOSPIRA |
| 075549 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2000/06/13
|
HIKMA |
| 078274 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2008/12/29
|
SAGENT PHARMS INC |
| 079001 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
Yes |
AP |
2009/06/17
|
SUN PHARM |
| 090243 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2010/05/11
|
MYLAN LABS LTD |
| 205390 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2016/05/26
|
GLAND |
| 206670 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2018/12/20
|
EUGIA PHARMA |
| 203725 |
001 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
10MG/VIAL |
Prescription |
No |
No |
AP |
2019/07/30
|
HIKMA |
活性成分:VECURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/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 |
|---|
| 074688 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
1999/08/25
|
MEITHEAL |
| 075164 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
1999/10/21
|
HOSPIRA |
| 075549 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2000/06/13
|
HIKMA |
| 078274 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2008/12/29
|
SAGENT PHARMS INC |
| 079001 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
Yes |
AP |
2009/06/17
|
SUN PHARM |
| 090243 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2010/05/11
|
MYLAN LABS LTD |
| 205390 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2016/05/26
|
GLAND |
| 206670 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2018/12/20
|
EUGIA PHARMA |
| 203725 |
002 |
ANDA |
VECURONIUM BROMIDE |
VECURONIUM BROMIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2019/07/30
|
HIKMA |
