药品注册申请号：214442
申请类型：ANDA (仿制药申请)
申请人：CHANGZHOU PHARM
申请人全名：CHANGZHOU PHARMACEUTICAL FACTORY
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 CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG No No AB 2023/01/27 2023/01/27 Prescription
002 CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG No No AB 2023/01/27 Prescription
003 CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG No No AB 2023/01/27 Prescription
004 CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG No No AB 2023/01/27 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
2023/01/27 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:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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
074477 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 1996/02/13 PRINSTON INC
074505 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 1996/02/13 HIKMA INTL PHARMS
074532 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 1997/03/28 WOCKHARDT
074677 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 1997/05/30 INNOGENIX
074737 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 1998/10/28 COREPHARMA
212809 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 2019/12/13 AJANTA PHARMA LTD
214442 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG Prescription No No AB 2023/01/27 CHANGZHOU PHARM
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格: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
074477 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 1996/02/13 PRINSTON INC
074505 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 1996/02/13 HIKMA INTL PHARMS
074532 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 1997/03/28 WOCKHARDT
074677 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 1997/05/30 INNOGENIX
074737 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 1998/10/28 COREPHARMA
212809 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 2019/12/13 AJANTA PHARMA LTD
214442 002 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG Prescription No No AB 2023/01/27 CHANGZHOU PHARM
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:50MG 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
074477 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 1996/02/13 PRINSTON INC
074505 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 1996/02/13 HIKMA INTL PHARMS
074532 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 1997/03/28 WOCKHARDT
074677 001 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 1997/05/30 INNOGENIX
074737 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 1998/10/28 COREPHARMA
212809 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 2019/12/13 AJANTA PHARMA LTD
214442 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG Prescription No No AB 2023/01/27 CHANGZHOU PHARM
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:100MG 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
074477 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 1996/02/13 PRINSTON INC
074505 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No Yes AB 1996/02/13 HIKMA INTL PHARMS
074532 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 1997/03/28 WOCKHARDT
074677 003 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 1997/05/30 INNOGENIX
074737 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 1998/10/28 COREPHARMA
212809 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 2019/12/13 AJANTA PHARMA LTD
214442 004 ANDA CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG Prescription No No AB 2023/01/27 CHANGZHOU PHARM
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