药品注册申请号：208829
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS CO
申请人全名：AMNEAL PHARMACEUTICALS CO GMBH
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 2017/05/24 2017/05/24 Discontinued
002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG No No AB 2017/05/24 Discontinued
003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2017/05/24 Discontinued
004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG No No AB 2017/05/24 Discontinued
005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG No No AB 2017/05/24 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2017/05/24 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/04/08 SUPPL-21（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert,Labeling-Container/Carton Labels 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: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 RESEARCH
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
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:7.5MG; 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
076008 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2013/07/08 MYLAN
202557 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2014/12/30 ACCORD HLTHCARE
202330 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2017/02/17 STRIDES PHARMA
208829 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Discontinued No No AB 2017/05/24 AMNEAL PHARMS CO
078246 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2020/02/21 AUROBINDO PHARMA LTD
075521 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2021/03/16 RUBICON RESEARCH
078888 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2023/03/21 ZYDUS PHARMS
202087 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2025/07/03 AIPING PHARM INC
075413 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2025/10/06 RISING
>>>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 RESEARCH
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
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 RESEARCH
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 No 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
210907 003 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No Yes AB 2019/11/14 UNICHEM
>>>活性成分:BUSPIRONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:30MG; 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 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2001/06/28 MYLAN
075022 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2004/03/25 TEVA
078302 001 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2007/12/17 OXFORD PHARMS
078246 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2009/02/27 AUROBINDO PHARMA LTD
078888 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2014/02/07 ZYDUS PHARMS
202330 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2014/08/25 STRIDES PHARMA
202557 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2014/12/30 ACCORD HLTHCARE
204582 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2015/09/18 HERITAGE PHARMA
202087 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2015/12/16 AIPING PHARM INC
208829 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Discontinued No No AB 2017/05/24 AMNEAL PHARMS CO
210907 004 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2019/11/14 UNICHEM
075521 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2021/03/16 RUBICON RESEARCH
075413 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2025/10/06 RISING
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