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
>>>原始批准或临时批准<<<
审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
1995/12/15 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
STANDARD
|
|
|
>>>补充申请<<<
审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
2022/10/14 |
SUPPL-28(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2022/10/07 |
SUPPL-29(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2018/07/26 |
SUPPL-26(补充) |
Approval |
Labeling-Container/Carton Labels |
STANDARD
|
|
|
2018/07/26 |
SUPPL-20(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2013/04/01 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/11/22 |
SUPPL-19(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2010/06/02 |
SUPPL-17(补充) |
Approval |
Labeling-Container/Carton Labels |
STANDARD
|
|
|
2003/07/18 |
SUPPL-9(补充) |
Approval |
Efficacy-Labeling Change With Clinical Data |
STANDARD
|
|
|
2002/10/15 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/06/04 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/02/25 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/02/25 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/05/21 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/05/21 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/03/26 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
1998/10/15 |
SUPPL-3(补充) |
Approval |
Efficacy-Labeling Change With Clinical Data |
STANDARD
|
|
|
1998/06/19 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
>>>活性成分:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AP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 |
020551 |
001 |
NDA |
NIMBEX |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |
020551 |
003 |
NDA |
NIMBEX PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |
>>>活性成分:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 |
020551 |
002 |
NDA |
NIMBEX PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |
>>>活性成分:CISATRACURIUM BESYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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 |
020551 |
001 |
NDA |
NIMBEX |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |
020551 |
003 |
NDA |
NIMBEX PRESERVATIVE FREE |
CISATRACURIUM BESYLATE |
INJECTABLE;INJECTION |
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
1995/12/15
|
ABBVIE |