药品注册申请号：020358
申请类型：NDA (新药申请)
申请人：GLAXOSMITHKLINE
申请人全名：GLAXOSMITHKLINE
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 SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 50MG No No None 1996/10/04 1996/10/04 Discontinued
002 WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Yes No AB1 1996/10/04 Prescription
003 WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Yes No AB1 1996/10/04 Prescription
004 WELLBUTRIN SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Yes Yes AB1 2002/06/14 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1996/10/04 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/11/05 SUPPL-70（补充） Approval Labeling-Package Insert STANDARD
2024/05/07 SUPPL-68（补充） Approval Labeling-Package Insert STANDARD
2022/12/06 SUPPL-66（补充） Approval Labeling-Package Insert STANDARD
2020/10/20 SUPPL-64（补充） Approval Labeling-Package Insert STANDARD
2019/11/05 SUPPL-61（补充） Approval Labeling-Package Insert STANDARD
2017/08/11 SUPPL-60（补充） Approval Labeling-Package Insert STANDARD
2017/05/10 SUPPL-58（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2017/05/04 SUPPL-59（补充） Approval Labeling-Patient Package Insert STANDARD
2016/04/25 SUPPL-57（补充） Approval Labeling-Package Insert STANDARD
2014/12/16 SUPPL-55（补充） Approval Labeling-Package Insert STANDARD
2014/07/17 SUPPL-56（补充） Approval Labeling-Package Insert 901 REQUIRED
2013/12/23 SUPPL-54（补充） Approval Labeling-Package Insert STANDARD
2013/12/23 SUPPL-53（补充） Approval Labeling-Package Insert STANDARD
2013/03/19 SUPPL-52（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2012/08/02 SUPPL-51（补充） Approval REMS-Modified
2011/07/25 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2011/05/17 SUPPL-49（补充） Approval Labeling-Package Insert,Labeling STANDARD
2011/05/17 SUPPL-39（补充） Approval Labeling STANDARD
2010/05/25 SUPPL-45（补充） Approval Labeling STANDARD
2010/02/26 SUPPL-48（补充） Approval REMS-Proposal,Labeling STANDARD
2009/07/01 SUPPL-47（补充） Approval Labeling STANDARD
2009/07/01 SUPPL-46（补充） Approval Labeling STANDARD
2007/08/02 SUPPL-43（补充） Approval Labeling STANDARD
2007/01/29 SUPPL-42（补充） Approval Labeling STANDARD
2006/07/03 SUPPL-40（补充） Approval Labeling STANDARD
2006/07/03 SUPPL-37（补充） Approval Labeling STANDARD
2006/02/28 SUPPL-35（补充） Approval Labeling STANDARD
2005/01/12 SUPPL-34（补充） Approval Labeling STANDARD
2004/05/27 SUPPL-32（补充） Approval Labeling STANDARD
2004/04/26 SUPPL-30（补充） Approval Labeling STANDARD
2002/10/22 SUPPL-29（补充） Approval Labeling STANDARD
2002/10/02 SUPPL-24（补充） Approval Labeling STANDARD
2002/07/12 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2002/07/12 SUPPL-26（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2002/06/20 SUPPL-23（补充） Approval Labeling STANDARD
2002/06/20 SUPPL-18（补充） Approval Labeling STANDARD
2002/06/14 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2002/02/13 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2001/06/11 SUPPL-19（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2000/10/11 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2000/10/11 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/10/11 SUPPL-20（补充） Approval Manufacturing (CMC)-Formulation STANDARD
2000/08/04 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/04/10 SUPPL-16（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-15（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-14（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-13（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-12（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-8（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-7（补充） Approval Labeling STANDARD
1999/04/06 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1999/04/06 SUPPL-10（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/04/06 SUPPL-9（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1999/01/26 SUPPL-2（补充） Approval Labeling STANDARD
1998/11/30 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1998/11/30 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/11/30 SUPPL-4（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/12/16 SUPPL-3（补充） Approval Labeling STANDARD
1997/12/16 SUPPL-1（补充） Approval Labeling 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 5358970 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5427798 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5731000 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5763493 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5358970 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5427798 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5731000 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5763493 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5358970 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5427798 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5731000 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5763493 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5358970 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5427798 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5731000 2013/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5763493 2013/08/12 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
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
090325 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2010/04/08 AUROBINDO PHARMA USA
091459 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB1 2011/06/09 PH HEALTH
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
207874 001 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB1 2025/05/02 IPCA LABS LTD
>>>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
090325 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2010/04/08 AUROBINDO PHARMA USA
091459 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Discontinued No No AB1 2011/06/09 PH HEALTH
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
207874 002 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 150MG Prescription No No AB1 2025/05/02 IPCA LABS LTD
>>>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
090325 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2010/04/08 AUROBINDO PHARMA USA
091459 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB1 2011/06/09 PH HEALTH
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
207874 003 ANDA BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB1 2025/05/02 IPCA LABS LTD
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