药品注册申请号:065361
申请类型:ANDA (仿制药申请)
申请人:CIPLA LTD
申请人全名:CIPLA 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 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) No No AP 2007/10/22 2007/10/22 Prescription
002 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) No No AP 2007/10/22 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
2020/01/27 SUPPL-11(补充) Approval Labeling STANDARD
2020/01/27 SUPPL-6(补充) Approval Labeling STANDARD
2014/12/20 SUPPL-5(补充) Approval Labeling STANDARD
2014/12/20 SUPPL-4(补充) Approval Labeling STANDARD
2014/12/20 SUPPL-2(补充) Approval Labeling
2007/10/22 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
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:EPIRUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/25ML (2MG/ML) 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
050778 002 NDA ELLENCE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription Yes No AP 1999/09/15 PFIZER INC
065289 001 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription No No AP 2007/06/27 HIKMA
065331 001 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription No No AP 2007/08/09 IMPAX LABS INC
065361 001 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription No No AP 2007/10/22 CIPLA LTD
065445 002 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Discontinued No No AP 2008/09/18 ACTAVIS TOTOWA
090163 001 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription No No AP 2009/06/24 EPIC PHARMA LLC
090075 001 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Prescription No No AP 2010/03/25 HISUN PHARM HANGZHOU
活性成分:EPIRUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/100ML (2MG/ML) 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
050778 001 NDA ELLENCE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Prescription Yes Yes AP 1999/09/15 PFIZER INC
065289 002 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2007/06/27 HIKMA
065331 002 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2007/08/09 IMPAX LABS INC
065361 002 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2007/10/22 CIPLA LTD
065445 003 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Discontinued No No AP 2008/09/18 ACTAVIS TOTOWA
090075 002 ANDA EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2010/03/25 HISUN PHARM HANGZHOU
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