药品注册申请号：075932
申请类型：ANDA (仿制药申请)
申请人：EPIC PHARMA LLC
申请人全名：EPIC PHARMA LLC
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 2003/11/25 2003/11/25 Prescription
002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG No No AB1 2004/03/22 Prescription
003 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG No No AB1 2005/06/22 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
2022/09/02 SUPPL-49（补充） Approval Labeling STANDARD
2021/01/11 SUPPL-47（补充） Approval Labeling STANDARD
2021/01/11 SUPPL-46（补充） Approval Labeling STANDARD
2021/01/11 SUPPL-43（补充） Approval Labeling STANDARD
2016/07/15 SUPPL-40（补充） Approval Labeling STANDARD
2016/07/15 SUPPL-38（补充） Approval Labeling STANDARD
2016/07/15 SUPPL-35（补充） Approval Labeling STANDARD
2014/11/20 SUPPL-34（补充） Approval Labeling STANDARD
2014/11/20 SUPPL-33（补充） Approval Labeling STANDARD
2012/04/18 SUPPL-31（补充） Approval Labeling
2010/10/25 SUPPL-30（补充） Approval Labeling
2010/09/08 SUPPL-29（补充） Approval Labeling
2010/04/05 SUPPL-27（补充） Approval Labeling
2009/11/05 SUPPL-26（补充） Approval Labeling
2008/10/31 SUPPL-24（补充） Approval Labeling
2008/02/05 SUPPL-21（补充） Approval Labeling
2007/06/04 SUPPL-20（补充） Approval Labeling
2006/11/06 SUPPL-18（补充） Approval Labeling
2005/08/01 SUPPL-15（补充） Approval Labeling
2005/06/22 SUPPL-13（补充） Approval Supplement
2005/06/22 SUPPL-12（补充） Approval Supplement
2005/06/22 SUPPL-5（补充） Approval Labeling
2005/06/22 SUPPL-4（补充） Approval Supplement
2004/11/18 SUPPL-14（补充） Approval Labeling
2004/11/18 SUPPL-10（补充） Approval Labeling
2004/11/18 SUPPL-3（补充） Approval Labeling
2004/04/28 SUPPL-9（补充） Approval Labeling
2004/03/22 SUPPL-2（补充） Approval Labeling
2004/03/22 SUPPL-1（补充） Approval Supplement
2003/11/25 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
无
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
无
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 EPIC PHARMA LLC
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 Discontinued No No AB1 2010/04/06 SUN PHARM
091459 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB1 2011/06/09 ENDO OPERATIONS
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 Discontinued 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
216800 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2023/05/31 ANNORA PHARMA
218385 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2024/10/17 GRANULES
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 EPIC PHARMA LLC
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 Discontinued No No AB1 2010/04/06 SUN PHARM
091459 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Discontinued No No AB1 2011/06/09 ENDO OPERATIONS
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 Discontinued 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
216800 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2023/05/31 ANNORA PHARMA
218385 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2024/10/17 GRANULES
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
075932 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2005/06/22 EPIC PHARMA LLC
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 Discontinued No No AB1 2010/04/06 SUN PHARM
091459 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2011/06/09 ENDO OPERATIONS
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 Discontinued 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
216800 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2023/05/31 ANNORA PHARMA
218385 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2024/10/17 GRANULES
更多信息
药品NDC数据与药品包装、标签说明书
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