药品注册申请号：078745
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL MOLECULAR
申请人全名：CHARTWELL MOLECULAR HOLDINGS LLC
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 RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG No No AB 2008/06/18 2008/06/18 Prescription
002 RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG No No AB 2008/06/18 Prescription
003 RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG No No AB 2008/06/18 Prescription
004 RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG No No AB 2008/06/18 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
2020/07/24 SUPPL-11（补充） Approval Labeling STANDARD
2016/02/28 SUPPL-9（补充） Approval Labeling STANDARD
2016/02/28 SUPPL-8（补充） Approval Labeling STANDARD
2014/09/26 SUPPL-7（补充） Approval Labeling STANDARD
2014/09/26 SUPPL-5（补充） Approval Labeling STANDARD
2014/09/26 SUPPL-3（补充） Approval Labeling
2011/05/19 SUPPL-2（补充） Approval Labeling
2009/10/22 SUPPL-1（补充） Approval Labeling
2008/06/18 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:RAMIPRIL 剂型/给药途径:CAPSULE;ORAL 规格:1.25MG 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
019901 001 NDA ALTACE RAMIPRIL CAPSULE;ORAL 1.25MG Prescription Yes No AB 1991/01/28 KING PHARMS LLC
076549 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2005/10/24 WATSON LABS
077626 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/06/09 LUPIN
077900 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/06/18 HIKMA
078191 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/06/18 DR REDDYS LABS LTD
078745 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/06/18 CHARTWELL MOLECULAR
079116 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/06/20 COREPHARMA
078832 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2008/09/02 ZYDUS PHARMS USA
091604 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Prescription No No AB 2011/06/08 AUROBINDO PHARMA LTD
202392 001 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 1.25MG Discontinued No No AB 2014/04/15 ACCORD HLTHCARE
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;ORAL 规格:2.5MG 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
019901 002 NDA ALTACE RAMIPRIL CAPSULE;ORAL 2.5MG Prescription Yes No AB 1991/01/28 KING PHARMS LLC
076549 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2005/10/24 WATSON LABS
077626 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/06/09 LUPIN
077900 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/06/18 HIKMA
078191 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/06/18 DR REDDYS LABS LTD
078745 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/06/18 CHARTWELL MOLECULAR
079116 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/06/20 COREPHARMA
078832 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2008/09/02 ZYDUS PHARMS USA
091604 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Prescription No No AB 2011/06/08 AUROBINDO PHARMA LTD
202392 002 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 2.5MG Discontinued No No AB 2014/04/15 ACCORD HLTHCARE
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;ORAL 规格:5MG 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
019901 003 NDA ALTACE RAMIPRIL CAPSULE;ORAL 5MG Prescription Yes No AB 1991/01/28 KING PHARMS LLC
077626 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/06/09 LUPIN
077900 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/06/18 HIKMA
078191 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/06/18 DR REDDYS LABS LTD
078745 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/06/18 CHARTWELL MOLECULAR
079116 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/06/20 COREPHARMA
078832 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2008/09/02 ZYDUS PHARMS USA
091604 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Prescription No No AB 2011/06/08 AUROBINDO PHARMA LTD
202392 003 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 5MG Discontinued No No AB 2014/04/15 ACCORD HLTHCARE
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;ORAL 规格:10MG 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
019901 004 NDA ALTACE RAMIPRIL CAPSULE;ORAL 10MG Prescription Yes Yes AB 1991/01/28 KING PHARMS LLC
076549 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2005/10/24 WATSON LABS
077626 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/06/09 LUPIN
077900 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/06/18 HIKMA
078191 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/06/18 DR REDDYS LABS LTD
078745 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/06/18 CHARTWELL MOLECULAR
079116 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/06/20 COREPHARMA
078832 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2008/09/02 ZYDUS PHARMS USA
091604 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Prescription No No AB 2011/06/08 AUROBINDO PHARMA LTD
202392 004 ANDA RAMIPRIL RAMIPRIL CAPSULE;ORAL 10MG Discontinued No No AB 2014/04/15 ACCORD HLTHCARE
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
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