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 |
2021/10/25 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/02/08 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/13 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/25 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
2017/08/09 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/12 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/12 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/10/23 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/18 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/08/02 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/01/08 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/30 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/10/22 |
SUPPL-28(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/01/28 |
SUPPL-27(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/06/26 |
SUPPL-23(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2009/05/04 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/07/29 |
SUPPL-21(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2008/07/21 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/02/16 |
SUPPL-15(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2004/09/29 |
SUPPL-12(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2004/03/17 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/03/17 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/07 |
SUPPL-7(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/12/10 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/11/21 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/11/15 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/09/20 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/09/20 |
SUPPL-1(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/06/12 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/04/11 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/01/26 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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:CASPOFUNGIN ACETATE 剂型/给药途径:POWDER;INTRAVENOUS 规格:50MG/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 |
021227 |
001 |
NDA |
CANCIDAS |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2001/01/26
|
MERCK |
206110 |
001 |
NDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2016/12/30
|
FRESENIUS KABI USA |
207092 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/29
|
GLAND |
200833 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2018/06/28
|
HENGRUI PHARMA |
205923 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Discontinued |
No |
No |
AP |
2018/07/02
|
XELLIA PHARMS APS |
211263 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/01
|
AREVA PHARMS |
活性成分:CASPOFUNGIN ACETATE 剂型/给药途径:POWDER;INTRAVENOUS 规格:70MG/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 |
021227 |
002 |
NDA |
CANCIDAS |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2001/01/26
|
MERCK |
206110 |
002 |
NDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2016/12/30
|
FRESENIUS KABI USA |
207092 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/29
|
GLAND |
200833 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2018/06/28
|
HENGRUI PHARMA |
205923 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Discontinued |
No |
No |
AP |
2018/07/02
|
XELLIA PHARMS APS |
211263 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/01
|
AREVA PHARMS |