药品注册申请号:063097
申请类型:ANDA (仿制药申请)
申请人:PHARMACHEMIE BV
申请人全名:PHARMACHEMIE BV
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 DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 10MG/VIAL No No AP 1990/05/21 1990/05/21 Discontinued
002 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 20MG/VIAL No No AP 1990/05/21 Discontinued
003 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL No No AP 1990/05/21 Discontinued
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
2003/08/14 SUPPL-21(补充) Approval Labeling
2002/09/19 SUPPL-18(补充) Approval Manufacturing (CMC)
2002/09/18 SUPPL-19(补充) Approval Labeling
2001/02/15 SUPPL-15(补充) Approval Manufacturing (CMC)
2000/08/25 SUPPL-17(补充) Approval Labeling
2000/08/25 SUPPL-16(补充) Approval Labeling
2000/03/30 SUPPL-14(补充) Approval Manufacturing (CMC)
1999/07/13 SUPPL-13(补充) Approval Labeling
1996/04/03 SUPPL-11(补充) Approval Labeling
1996/01/29 SUPPL-10(补充) Approval Labeling
1996/01/29 SUPPL-9(补充) Approval Manufacturing (CMC)
1996/01/29 SUPPL-8(补充) Approval Manufacturing (CMC)
1996/01/29 SUPPL-7(补充) Approval Manufacturing (CMC)
1996/01/29 SUPPL-6(补充) Approval Manufacturing (CMC)
1995/06/07 SUPPL-12(补充) Approval Manufacturing (CMC)
1994/07/26 SUPPL-5(补充) Approval Manufacturing (CMC)
1992/03/31 SUPPL-3(补充) Approval Manufacturing (CMC)
1992/03/31 SUPPL-2(补充) Approval Labeling
1990/05/21 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:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/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
063097 001 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 10MG/VIAL Discontinued No No AP 1990/05/21 PHARMACHEMIE BV
活性成分:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/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
062921 002 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No Yes AP 1989/03/17 HIKMA
063097 002 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 20MG/VIAL Discontinued No No AP 1990/05/21 PHARMACHEMIE BV
208888 001 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2017/02/17 AMNEAL
活性成分:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 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
062921 003 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL Prescription No Yes AP 1989/03/17 HIKMA
063097 003 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL Discontinued No No AP 1990/05/21 PHARMACHEMIE BV
200170 002 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL Prescription No No AP 2011/10/28 MYLAN LABS LTD
208888 002 ANDA DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/VIAL Prescription No No AP 2017/02/17 AMNEAL
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