药品注册申请号：207762
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 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 10MG BASE No No AB 2019/01/11 2019/01/11 Prescription
002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 20MG BASE No No AB 2019/01/11 Prescription
003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 40MG BASE No No AB 2019/01/11 Prescription
004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE No No AB 2019/01/11 Prescription
005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE No No AB 2019/01/11 Prescription
006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE No No AB 2019/01/11 Prescription
007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE No No AB 2019/01/11 Prescription
008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE No No AB 2019/01/11 Prescription
009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE No No AB 2019/01/11 Prescription
010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE No No AB 2019/01/11 Prescription
011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE No No AB 2019/01/11 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
2023/09/18 SUPPL-6（补充） Approval Labeling STANDARD
2023/09/18 SUPPL-4（补充） Approval Labeling STANDARD
2023/09/18 SUPPL-2（补充） Approval Labeling STANDARD
2023/09/18 SUPPL-1（补充） Approval Labeling STANDARD
2019/01/11 ORIG-1（原始申请） 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
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:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 2.5MG BASE;EQ 10MG BASE 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
021540 009 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 10MG BASE Prescription Yes No AB 2004/07/29 PHARMACIA
203874 001 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 10MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 001 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 10MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 2.5MG BASE;EQ 20MG BASE 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
021540 010 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 20MG BASE Prescription Yes No AB 2004/07/29 PHARMACIA
203874 002 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 20MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 002 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 20MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 2.5MG BASE;EQ 40MG BASE 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
021540 011 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 40MG BASE Prescription Yes No AB 2004/07/29 PHARMACIA
203874 003 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 40MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 003 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 2.5MG BASE;EQ 40MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;EQ 10MG BASE 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
021540 001 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 004 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 004 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 004 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 001 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 10MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;EQ 20MG BASE 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
021540 002 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 005 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 005 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 005 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 002 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 20MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;EQ 40MG BASE 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
021540 003 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 006 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 006 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 006 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 003 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 40MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;EQ 80MG BASE 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
021540 004 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 007 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 007 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 007 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 004 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE;EQ 80MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;EQ 10MG BASE 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
021540 005 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 008 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 008 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 008 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 005 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 10MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;EQ 20MG BASE 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
021540 006 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 009 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 009 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 009 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 006 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 20MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;EQ 40MG BASE 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
021540 007 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE Prescription Yes No AB 2004/01/30 PHARMACIA
200465 010 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 010 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 010 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 007 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 40MG BASE Prescription No No AB 2019/11/18 APOTEX
活性成分:AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;EQ 80MG BASE 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
021540 008 NDA CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE Prescription Yes Yes AB 2004/01/30 PHARMACIA
200465 011 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE Prescription No No AB 2013/11/29 MYLAN
203874 011 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE Prescription No No AB 2014/03/07 DR REDDYS
207762 011 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
205199 008 ANDA AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE;EQ 80MG BASE Prescription No No AB 2019/11/18 APOTEX
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