药品注册申请号:206641
申请类型:ANDA (仿制药申请)
申请人:ZYDUS PHARMS
申请人全名:ZYDUS PHARMACEUTICALS USA 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 CAPSULE, EXTENDED RELEASE;ORAL 120MG No No AB4 2017/08/11 2017/08/11 Prescription
002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG No No AB4 2017/08/11 Prescription
003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG No No AB4 2017/08/11 Prescription
004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG No No AB4 2017/08/11 Prescription
005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG No No AB4 2017/08/11 Prescription
006 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG No No AB4 2017/08/11 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
2017/08/11 ORIG 1 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:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:120MG 治疗等效代码:AB4
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
020401 001 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 001 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2010/11/15 SUN PHARM
091022 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2012/09/28 SANDOZ
206641 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:180MG 治疗等效代码:AB4
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
020401 002 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 002 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2010/11/15 SUN PHARM
091022 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2012/09/28 SANDOZ
206641 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:240MG 治疗等效代码:AB4
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
020401 003 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 003 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2010/11/15 SUN PHARM
091022 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2012/09/28 SANDOZ
206641 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:300MG 治疗等效代码:AB4
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
020401 004 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 004 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2010/11/15 SUN PHARM
091022 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2012/09/28 SANDOZ
206641 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:360MG 治疗等效代码:AB4
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
020401 005 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 005 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2010/11/15 SUN PHARM
091022 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2012/09/28 SANDOZ
206641 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:420MG 治疗等效代码:AB4
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
020401 006 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription Yes Yes AB4 1998/10/16 BAUSCH
091022 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription No No AB4 2012/09/28 SANDOZ
206641 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
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