药品注册申请号:075491
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA USA
申请人全名:AUROBINDO PHARMA USA 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;ORAL 75MG No No AB 2000/04/17 2000/04/17 Prescription
002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2000/04/17 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/05/07 SUPPL-40(补充) Approval Labeling STANDARD
2022/10/18 SUPPL-38(补充) Approval Labeling STANDARD
2022/10/18 SUPPL-37(补充) Approval Labeling STANDARD
2022/10/18 SUPPL-36(补充) Approval Labeling STANDARD
2022/10/18 SUPPL-35(补充) Approval Labeling STANDARD
2022/10/18 SUPPL-33(补充) Approval Labeling STANDARD
2015/05/22 SUPPL-31(补充) Approval Labeling STANDARD
2015/05/22 SUPPL-30(补充) Approval Labeling STANDARD
2014/09/14 SUPPL-28(补充) Approval Labeling STANDARD
2014/02/07 SUPPL-27(补充) Approval Labeling STANDARD
2014/02/07 SUPPL-26(补充) Approval Labeling STANDARD
2010/04/22 SUPPL-24(补充) Approval REMS
2009/12/10 SUPPL-23(补充) Approval Labeling
2009/01/26 SUPPL-22(补充) Approval Labeling
2008/09/08 SUPPL-16(补充) Approval Labeling
2008/01/16 SUPPL-14(补充) Approval Labeling
2008/01/16 SUPPL-13(补充) Approval Labeling
2007/05/01 SUPPL-12(补充) Approval Labeling
2006/02/06 SUPPL-7(补充) Approval Labeling
2005/04/08 SUPPL-6(补充) Approval Labeling
2004/02/06 SUPPL-5(补充) Approval Labeling
2002/08/26 SUPPL-2(补充) Approval Labeling
2000/04/17 ORIG-1(原始申请) 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 AUROBINDO PHARMA USA
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 Discontinued 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
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 AUROBINDO PHARMA USA
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 Discontinued 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
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
更多信息
药品NDC数据与药品包装、标签说明书
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