药品注册申请号:075584
申请类型:ANDA (仿制药申请)
申请人:APNAR PHARMA LP
申请人全名:APNAR PHARMA LP
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 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG No No AB 2000/02/07 2000/02/07 Prescription
002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2000/02/07 Prescription
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
2015/05/16 SUPPL 42 Approval Labeling STANDARD
2015/05/16 SUPPL 41 Approval Labeling STANDARD
2014/09/24 SUPPL 38 Approval Labeling STANDARD
2014/09/24 SUPPL 36 Approval Labeling STANDARD
2012/03/28 SUPPL 34 Approval Labeling
2012/03/27 SUPPL 33 Approval Labeling
2010/07/08 SUPPL 32 Approval REMS
2010/03/04 SUPPL 31 Approval Labeling
2009/11/16 SUPPL 27 Approval Labeling
2008/12/19 SUPPL 23 Approval Labeling
2008/01/16 SUPPL 20 Approval Labeling
2007/12/19 SUPPL 24 Approval Labeling
2007/02/08 SUPPL 19 Approval Labeling
2007/02/08 SUPPL 14 Approval Labeling
2005/06/01 SUPPL 12 Approval Labeling
2004/02/04 SUPPL 9 Approval Labeling
2002/11/05 SUPPL 7 Approval Labeling
2002/01/18 SUPPL 3 Approval Manufacturing (CMC)
2002/01/18 SUPPL 2 Approval Manufacturing (CMC)
2000/02/07 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:BUPROPION HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:75MG 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
075584 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2000/02/07 APNAR PHARMA LP
075491 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2000/04/17 MYLAN
076143 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2006/01/17 APOTEX INC
206975 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2016/08/19 HERITAGE PHARMA
207389 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2017/09/18 INVAGEN PHARMS
203013 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2018/06/08 ALEMBIC PHARMS LTD
208606 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2020/01/16 CADILA PHARMS LTD
207403 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2020/04/17 MICRO LABS
活性成分:BUPROPION HYDROCHLORIDE 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
075584 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2000/02/07 APNAR PHARMA LP
075491 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2000/04/17 MYLAN
076143 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No Yes AB 2006/01/17 APOTEX INC
206975 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2016/08/19 HERITAGE PHARMA
207389 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/09/18 INVAGEN PHARMS
203013 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2018/06/08 ALEMBIC PHARMS LTD
208606 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/01/16 CADILA PHARMS LTD
207403 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/04/17 MICRO LABS
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