药品注册申请号：074253
申请类型：ANDA (仿制药申请)
申请人：IMPAX LABS INC
申请人全名：IMPAX LABORATORIES 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 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2001/03/28 2001/03/28 Prescription
002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2001/03/28 Prescription
003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG No No AB 2002/03/13 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
2020/05/29 SUPPL-8（补充） Approval Labeling STANDARD
2012/10/31 SUPPL-5（补充） Approval Labeling
2008/06/03 SUPPL-4（补充） Approval Labeling
2002/03/13 SUPPL-2（补充） Approval Labeling
2002/03/13 SUPPL-1（补充） Approval Manufacturing (CMC)
2001/03/28 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:BUSPIRONE HYDROCHLORIDE 剂型/给药途径:TABLET;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
074253 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2001/03/28 IMPAX LABS INC
075022 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2002/02/28 TEVA
076008 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2002/03/01 MYLAN
075521 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2002/04/05 RUBICON
075388 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2002/05/09 OXFORD PHARMS
078246 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2009/02/27 AUROBINDO PHARMA LTD
078888 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/02/07 ZYDUS PHARMS
202330 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/08/25 STRIDES PHARMA
202557 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/12/30 ACCORD HLTHCARE
204582 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/09/18 HERITAGE PHARMA
202087 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/12/16 AIPING PHARM INC
208829 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2017/05/24 AMNEAL PHARMS CO
209696 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/05/03 INVENTIA HLTHCARE
208972 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/04/16 EPIC PHARMA LLC
210907 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/11/14 UNICHEM
活性成分:BUSPIRONE HYDROCHLORIDE 剂型/给药途径:TABLET;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
074253 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2001/03/28 IMPAX LABS INC
075022 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2002/02/28 TEVA
076008 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2002/03/01 MYLAN
075521 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2002/04/05 RUBICON
075388 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2002/05/09 OXFORD PHARMS
078246 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2009/02/27 AUROBINDO PHARMA LTD
078888 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/02/07 ZYDUS PHARMS
202330 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/08/25 STRIDES PHARMA
202557 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/12/30 ACCORD HLTHCARE
204582 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/09/18 HERITAGE PHARMA
202087 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/12/16 AIPING PHARM INC
208829 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2017/05/24 AMNEAL PHARMS CO
209696 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/05/03 INVENTIA HLTHCARE
208972 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/04/16 EPIC PHARMA LLC
210907 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/11/14 UNICHEM
活性成分:BUSPIRONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:15MG 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
076008 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2001/03/28 MYLAN
075022 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2002/02/28 TEVA
074253 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2002/03/13 IMPAX LABS INC
075521 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2002/04/05 RUBICON
075388 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2002/05/09 OXFORD PHARMS
078246 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2009/02/27 AUROBINDO PHARMA LTD
078888 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2014/02/07 ZYDUS PHARMS
202330 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2014/08/25 STRIDES PHARMA
202557 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No Yes AB 2014/12/30 ACCORD HLTHCARE
204582 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2015/09/18 HERITAGE PHARMA
202087 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2015/12/16 AIPING PHARM INC
208829 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Discontinued No No AB 2017/05/24 AMNEAL PHARMS CO
209696 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2018/05/03 INVENTIA HLTHCARE
208972 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2019/04/16 EPIC PHARMA LLC
210907 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2019/11/14 UNICHEM
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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