药品注册申请号：021515
申请类型：NDA (新药申请)
申请人：BAUSCH
申请人全名：BAUSCH HEALTH US 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 WELLBUTRIN XL BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Yes No AB3 2003/08/28 2003/08/28 Prescription
002 WELLBUTRIN XL BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Yes Yes AB3 2003/08/28 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
2022/03/04 SUPPL-44（补充） Approval Labeling STANDARD
2021/07/08 SUPPL-43（补充） Approval Labeling STANDARD
2019/11/05 SUPPL-40（补充） Approval Labeling STANDARD
2017/05/04 SUPPL-36（补充） Approval Labeling STANDARD
2016/08/30 SUPPL-34（补充） Approval Labeling STANDARD
2016/05/24 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
2014/12/30 SUPPL-30（补充） Approval Labeling STANDARD
2014/12/30 SUPPL-29（补充） Approval Labeling STANDARD
2014/11/21 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2014/07/11 SUPPL-32（补充） Approval Labeling 901 REQUIRED
2012/08/02 SUPPL-28（补充） Approval REMS N/A
2011/07/26 SUPPL-27（补充） Approval Labeling STANDARD
2011/07/26 SUPPL-26（补充） Approval Labeling STANDARD
2010/05/25 SUPPL-22（补充） Approval Labeling STANDARD
2010/02/26 SUPPL-25（补充） Approval Labeling STANDARD
2009/07/01 SUPPL-24（补充） Approval Labeling STANDARD
2009/07/01 SUPPL-23（补充） Approval Labeling STANDARD
2007/08/02 SUPPL-20（补充） Approval Labeling STANDARD
2006/07/03 SUPPL-14（补充） Approval Labeling STANDARD
2006/06/12 SUPPL-18（补充） Approval Labeling STANDARD
2006/06/12 SUPPL-10（补充） Approval Efficacy PRIORITY
2006/02/28 SUPPL-12（补充） Approval Labeling STANDARD
2005/01/12 SUPPL-9（补充） Approval Labeling STANDARD
2004/10/28 SUPPL-2（补充） Approval Labeling STANDARD
2004/05/27 SUPPL-7（补充） Approval Labeling STANDARD
2003/08/28 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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
001 6096341 2018/10/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6143327 2018/10/30 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6096341 2018/10/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6143327 2018/10/30 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-497 2009/06/12**本条是由Drugfuture回溯的历史信息**
002 I-497 2009/06/12**本条是由Drugfuture回溯的历史信息**
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:AB3
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
021515 001 NDA WELLBUTRIN XL BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription Yes No AB3 2003/08/28 BAUSCH
077285 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2008/11/26 WATSON LABS INC
077715 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2008/11/26 ACTAVIS LABS FL INC
202189 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2012/11/21 WOCKHARDT LTD
206556 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Discontinued No No AB3 2016/08/26 INVAGEN PHARMS
090693 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2017/04/06 LUPIN LTD
207479 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2017/04/12 SCIEGEN PHARMS INC
207224 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2017/06/30 ANBISON LAB
208652 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2017/08/21 SINOTHERAPEUTICS INC
210081 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2017/11/03 TWI PHARMS
210015 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2018/06/14 YICHANG HUMANWELL
201567 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2018/07/23 ZYDUS PHARMS
210497 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2018/10/31 ACCORD HLTHCARE
211020 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2019/01/28 GRAVITI PHARMS
211200 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2020/04/29 ZHEJIANG JUTAI PHARM
200216 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2020/11/30 SUN PHARM
215568 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB3 2022/02/02 GRANULES
活性成分:BUPROPION HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:300MG 治疗等效代码:AB3
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
021515 002 NDA WELLBUTRIN XL BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription Yes Yes AB3 2003/08/28 BAUSCH
077284 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB3 2006/12/14 ANCHEN PHARMS
077285 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2008/08/15 WATSON LABS INC
201567 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2014/01/17 ZYDUS PHARMS
206556 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB3 2016/08/26 INVAGEN PHARMS
090693 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/04/06 LUPIN LTD
207479 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/04/12 SCIEGEN PHARMS INC
207224 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/06/30 ANBISON LAB
208652 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/08/21 SINOTHERAPEUTICS INC
210081 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/11/03 TWI PHARMS
210015 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2018/06/14 YICHANG HUMANWELL
210497 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2018/10/31 ACCORD HLTHCARE
211020 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2019/01/28 GRAVITI PHARMS
211200 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2019/09/05 ZHEJIANG JUTAI PHARM
203650 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2020/12/31 SUN PHARM
202189 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2022/01/28 WOCKHARDT LTD
215568 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2022/02/02 GRANULES
更多信息
药品NDC数据与药品包装、标签说明书
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