药品注册申请号:076711
申请类型:ANDA (仿制药申请)
申请人:IMPAX LABS
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 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG No No AB1 2004/12/03 2004/12/03 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
2015/09/29 SUPPL 27 Approval Labeling STANDARD
2015/09/29 SUPPL 24 Approval Labeling STANDARD
2015/09/29 SUPPL 23 Approval Labeling STANDARD
2015/09/29 SUPPL 19 Approval Labeling STANDARD
2012/02/21 SUPPL 14 Approval Labeling
2012/02/21 SUPPL 13 Approval Labeling
2010/08/18 SUPPL 12 Approval Labeling
2010/07/08 SUPPL 11 Approval REMS
2010/01/27 SUPPL 9 Approval Labeling
2008/01/16 SUPPL 7 Approval Labeling
2006/10/05 SUPPL 5 Approval Labeling
2006/02/14 SUPPL 3 Approval Labeling
2004/12/03 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, EXTENDED RELEASE;ORAL 规格:200MG 治疗等效代码:AB1
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
020358 004 NDA WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription Yes Yes AB1 2002/06/14 GLAXOSMITHKLINE
076711 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2004/12/03 IMPAX LABS
075932 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2005/06/22 SANDOZ
079095 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2009/03/24 ACTAVIS LABS FL INC
078866 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2010/04/06 SUN PHARM
091459 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2011/06/09 ANCHEN PHARMS
203969 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2014/10/31 TORRENT
202304 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2015/05/26 PRINSTON INC
206674 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2016/02/09 INVAGEN PHARMS
205794 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2016/03/01 SCIEGEN PHARMS INC
211347 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2018/10/16 YICHANG HUMANWELL
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