药品注册申请号:075913
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 100MG No No AB1 2004/01/28 2004/01/28 Prescription
002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG No No AB1 2004/03/22 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
2014/09/24 SUPPL 23 Approval Labeling STANDARD
2011/10/21 SUPPL 21 Approval Labeling
2011/10/21 SUPPL 20 Approval Labeling
2010/08/02 SUPPL 19 Approval Labeling
2010/05/24 SUPPL 18 Approval Labeling
2010/05/10 SUPPL 17 Approval REMS
2010/04/05 SUPPL 16 Approval Labeling
2004/03/22 SUPPL 3 Approval Labeling
2004/03/22 SUPPL 2 Approval Supplement
2004/03/22 SUPPL 1 Approval Supplement
2004/01/28 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:BUPROPION HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:100MG 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 002 NDA WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB1 1996/10/04 GLAXOSMITHKLINE
075932 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2003/11/25 SANDOZ
075913 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2004/01/28 IMPAX LABS
079095 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2009/03/24 ACTAVIS LABS FL INC
078866 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2010/04/06 SUN PHARM
091459 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2011/06/09 ANCHEN PHARMS
203969 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2014/10/31 TORRENT
202304 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2015/05/26 PRINSTON INC
206674 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2016/02/09 INVAGEN PHARMS
205794 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2016/03/01 SCIEGEN PHARMS INC
211347 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2018/10/16 YICHANG HUMANWELL
活性成分:BUPROPION HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:150MG 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 003 NDA WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription Yes No AB1 1996/10/04 GLAXOSMITHKLINE
075913 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2004/03/22 IMPAX LABS
075932 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2004/03/22 SANDOZ
079095 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2009/03/24 ACTAVIS LABS FL INC
078866 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2010/04/06 SUN PHARM
091459 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2011/06/09 ANCHEN PHARMS
203969 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2014/10/31 TORRENT
202304 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2015/05/26 PRINSTON INC
206674 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2016/02/09 INVAGEN PHARMS
205794 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2016/03/01 SCIEGEN PHARMS INC
211347 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2018/10/16 YICHANG HUMANWELL
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