药品注册申请号:077686
申请类型:ANDA (仿制药申请)
申请人:ACTAVIS LABS FL INC
申请人全名:ACTAVIS LABORATORIES FL 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, EXTENDED RELEASE;ORAL 420MG No No AB 2010/03/15 2010/03/15 Prescription
002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 360MG No No AB 2010/03/15 Prescription
003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG No No AB 2010/03/15 Prescription
004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG No No AB 2010/03/15 Prescription
005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG No No AB 2010/03/15 Prescription
006 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG No No AB 2010/03/15 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
2024/08/13 SUPPL-19(补充) Approval Labeling STANDARD
2024/07/16 SUPPL-11(补充) Approval Labeling STANDARD
2016/11/08 SUPPL-10(补充) Approval Labeling STANDARD
2011/04/21 SUPPL-5(补充) Approval Labeling
2010/03/15 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:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:420MG 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
021392 006 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 420MG Prescription Yes Yes AB 2003/02/06 BAUSCH
077686 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 420MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 420MG Prescription No No AB 2023/03/07 AMTA
216327 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 420MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:360MG 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
021392 005 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 360MG Prescription Yes No AB 2003/02/06 BAUSCH
077686 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 360MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 360MG Prescription No No AB 2023/03/07 AMTA
216327 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 360MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:300MG 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
021392 004 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB 2003/02/06 BAUSCH
077686 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/03/07 AMTA
216327 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:240MG 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
021392 003 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG Prescription Yes No AB 2003/02/06 BAUSCH
077686 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG Prescription No No AB 2023/03/07 AMTA
216327 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:180MG 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
021392 002 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription Yes No AB 2003/02/06 BAUSCH
077686 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription No No AB 2023/03/07 AMTA
216327 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
021392 001 NDA CARDIZEM LA DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB 2003/02/06 BAUSCH
077686 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2010/03/15 ACTAVIS LABS FL INC
216439 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2023/03/07 AMTA
216327 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2023/04/06 SCIEGEN PHARMS INC
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