药品注册申请号:200833
申请类型:ANDA (仿制药申请)
申请人:HENGRUI PHARMA
申请人全名:JIANGSU HENGRUI PHARMACEUTICALS CO LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE POWDER;INTRAVENOUS 50MG/VIAL No No AP 2018/06/28 2018/06/28 Prescription
002 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE POWDER;INTRAVENOUS 70MG/VIAL No No AP 2018/06/28 Prescription
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
2024/09/04 SUPPL-7(补充) Approval Labeling STANDARD
2019/08/02 SUPPL-3(补充) Approval Labeling STANDARD
2018/06/28 ORIG-1(原始申请) Approval Not Applicable
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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RLDRSTE 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
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