药品注册申请号:208657
申请类型:ANDA (仿制药申请)
申请人:DR REDDYS
申请人全名:DR REDDYS LABORATORIES 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 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) No No AB 2017/05/15 2017/05/15 Prescription
002 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) No No AB 2017/05/15 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
2020/06/26 SUPPL-4(补充) Approval Labeling STANDARD
2017/11/03 SUPPL-1(补充) Approval Labeling STANDARD
2017/05/15 ORIG-1(原始申请) Approval STANDARD
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:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE, LIPOSOMAL;INJECTION 规格:20MG/10ML (2MG/ML) 治疗等效代码:AB
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
050718 001 NDA DOXIL (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription Yes No AB 1995/11/17 BAXTER HLTHCARE CORP
203263 001 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription No Yes AB 2013/02/04 SUN PHARM
208657 001 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription No No AB 2017/05/15 DR REDDYS
212299 001 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription No No AB 2020/09/10 ZYDUS
207228 001 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription No No AB 2021/10/12 AYANA PHARMA LTD
212219 001 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 20MG/10ML (2MG/ML) Prescription No No AB 2022/10/19 BAXTER HLTHCARE CORP
活性成分:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE, LIPOSOMAL;INJECTION 规格:50MG/25ML (2MG/ML) 治疗等效代码:AB
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
050718 002 NDA DOXIL (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription Yes No AB 2000/06/13 BAXTER HLTHCARE CORP
203263 002 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription No Yes AB 2013/02/04 SUN PHARM
208657 002 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription No No AB 2017/05/15 DR REDDYS
212299 002 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription No No AB 2020/09/10 ZYDUS
207228 002 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription No No AB 2021/10/12 AYANA PHARMA LTD
212219 002 ANDA DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL;INJECTION 50MG/25ML (2MG/ML) Prescription No No AB 2022/10/19 BAXTER HLTHCARE CORP
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