药品注册申请号:075914
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 150MG No No AB2 2004/05/27 2004/05/27 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
2017/06/30 SUPPL 29 Approval Labeling STANDARD
2016/01/04 SUPPL 25 Approval Labeling STANDARD
2014/09/24 SUPPL 20 Approval Labeling STANDARD
2014/09/24 SUPPL 16 Approval Labeling STANDARD
2012/04/10 SUPPL 15 Approval Labeling
2011/06/24 SUPPL 14 Approval Labeling
2010/05/13 SUPPL 13 Approval REMS
2010/01/25 SUPPL 12 Approval Labeling
2004/05/27 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:150MG 治疗等效代码:AB2
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
075914 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB2 2004/05/27 IMPAX LABS
077475 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB2 2008/03/12 SANDOZ INC
079094 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No Yes AB2 2009/03/24 ACTAVIS LABS FL INC
091520 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB2 2011/06/09 ANCHEN PHARMS
206122 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB2 2016/08/17 SCIEGEN PHARMS INC
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