药品注册申请号：074752
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 CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG No No AB3 1998/07/09 1998/07/09 Prescription
002 CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG No No AB3 1998/07/09 Prescription
003 CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG No No AB3 1998/07/09 Prescription
004 CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG No No AB3 1998/07/09 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
2011/10/28 SUPPL-38（补充） Approval Labeling
2007/05/11 SUPPL-26（补充） Approval Labeling
2006/12/04 SUPPL-25（补充） Approval Labeling
2003/11/18 SUPPL-18（补充） Approval Supplement
2002/12/24 SUPPL-17（补充） Approval Manufacturing (CMC)
2002/10/11 SUPPL-16（补充） Approval Manufacturing (CMC)
2002/02/27 SUPPL-15（补充） Approval Manufacturing (CMC)
2001/01/08 SUPPL-13（补充） Approval Manufacturing (CMC)
2001/01/08 SUPPL-12（补充） Approval Manufacturing (CMC)
2000/08/16 SUPPL-11（补充） Approval Manufacturing (CMC)
2000/07/18 SUPPL-8（补充） Approval Manufacturing (CMC)
2000/05/12 SUPPL-9（补充） Approval Manufacturing (CMC)
1999/06/08 SUPPL-7（补充） Approval Labeling
1999/06/08 SUPPL-6（补充） Approval Labeling
1999/06/08 SUPPL-4（补充） Approval Manufacturing (CMC)
1999/06/08 SUPPL-3（补充） Approval Manufacturing (CMC)
1999/06/08 SUPPL-2（补充） Approval Manufacturing (CMC)
1999/06/08 SUPPL-1（补充） Approval Manufacturing (CMC)
1999/04/02 SUPPL-5（补充） Approval Labeling
1998/07/09 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
无
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
无
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:180MG 治疗等效代码:AB3
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
020062 002 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 001 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1999/12/20 ENDO OPERATIONS
075116 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2017/06/08 SUN PHARM
206534 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2024/11/08 ALEMBIC
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:AB3
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
020062 001 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB3 1992/08/10 BAUSCH
074752 002 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1999/12/20 ENDO OPERATIONS
075116 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2017/06/08 SUN PHARM
206534 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2024/11/08 ALEMBIC
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:AB3
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
020062 003 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 003 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1999/12/20 ENDO OPERATIONS
075116 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2017/06/08 SUN PHARM
206534 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2024/11/08 ALEMBIC
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:AB3
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
020062 004 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 004 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1999/12/20 ENDO OPERATIONS
075116 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/06/08 SUN PHARM
206534 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2024/11/08 ALEMBIC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database