药品注册申请号:075467
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS 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 None 2001/03/28 2002/02/28 Discontinued
002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG No No AB 2001/03/28 Prescription
003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG No No None 2002/02/28 Discontinued
004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG No No None 2002/02/28 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2020/05/28 SUPPL 21 Approval Labeling STANDARD
2012/05/30 SUPPL 17 Approval Labeling STANDARD
2008/05/13 SUPPL 15 Approval Labeling
2002/12/23 SUPPL 9 Approval Manufacturing (CMC)
2002/08/23 SUPPL 8 Approval Labeling
2002/08/23 SUPPL 7 Approval Manufacturing (CMC)
2002/07/18 SUPPL 6 Approval Labeling
2002/02/28 SUPPL 5 Approval Manufacturing (CMC)
2002/02/28 SUPPL 4 Approval Labeling
2002/02/28 SUPPL 3 Approval Manufacturing (CMC)
2002/02/28 SUPPL 2 Approval Labeling
2001/04/23 SUPPL 1 Approval Manufacturing (CMC)
2001/03/28 ORIG 1 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
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
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: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
078246 005 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No AB -- AUROBINDO PHARMA LTD
075467 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2001/03/28 MYLAN
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 Prescription No No AB 2017/05/24 AMNEAL PHARMS CO
209696 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2018/05/03 INVENTIA HLTHCARE
208972 002 ANDA BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2019/04/16 EPIC PHARMA LLC
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