药品注册申请号:072838
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS INC
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 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG No No AB 1992/11/05 1992/11/05 Prescription
002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG No No AB 1992/11/05 Prescription
003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG No No AB 1992/11/05 Prescription
004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG No No AB 1992/11/05 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2011/11/29 SUPPL 19 Approval Labeling
2007/04/12 SUPPL 11 Approval Manufacturing (CMC)
1999/07/12 SUPPL 7 Approval Manufacturing (CMC)
1996/12/12 SUPPL 6 Approval Labeling
1995/08/29 SUPPL 4 Approval Labeling
1995/08/29 SUPPL 3 Approval Manufacturing (CMC)
1995/07/13 SUPPL 5 Approval Labeling
1993/12/13 SUPPL 2 Approval Labeling
1992/11/05 ORIG 1 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:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:120MG 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
018602 004 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription Yes Yes AB 1986/12/08 BAUSCH
072838 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 1992/11/05 MYLAN
074185 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 1995/05/31 TEVA
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:90MG 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
018602 003 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription Yes No AB 1986/12/08 BAUSCH
072838 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription No No AB 1992/11/05 MYLAN
074185 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription No No AB 1995/05/31 TEVA
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:60MG 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
018602 002 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription Yes No AB 1982/11/05 BAUSCH
072838 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1992/11/05 MYLAN
074185 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1995/05/31 TEVA
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:30MG 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
018602 001 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription Yes No AB 1982/11/05 BAUSCH
072838 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 1992/11/05 MYLAN
074185 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 1995/05/31 TEVA
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