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 |
2014/01/08 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2013/02/16 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/05/24 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/24 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/02/26 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/08/27 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1996/03/18 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/06/08 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/05/31 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/02/09 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1989/08/16 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/14 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/12 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/10 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/04/09 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1986/10/24 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/10/24 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/10/24 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/06 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/10/16 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
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:PENTAMIDINE ISETHIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:300MG/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 |
019264 |
001 |
NDA |
PENTAM |
PENTAMIDINE ISETHIONATE |
INJECTABLE;INJECTION |
300MG/VIAL |
Prescription |
Yes |
Yes |
AP |
1984/10/16
|
FRESENIUS KABI USA |
206666 |
001 |
ANDA |
PENTAMIDINE ISETHIONATE |
PENTAMIDINE ISETHIONATE |
INJECTABLE;INJECTION |
300MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/28
|
SETON PHARMS |
213806 |
001 |
ANDA |
PENTAMIDINE ISETHIONATE |
PENTAMIDINE ISETHIONATE |
INJECTABLE;INJECTION |
300MG/VIAL |
Prescription |
No |
No |
AP |
2021/01/07
|
AVET LIFESCIENCES |
206982 |
001 |
ANDA |
PENTAMIDINE ISETHIONATE |
PENTAMIDINE ISETHIONATE |
INJECTABLE;INJECTION |
300MG/VIAL |
Prescription |
No |
No |
AP |
2022/03/17
|
XGEN PHARMS |