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 |
2022/12/06 |
SUPPL-66(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/20 |
SUPPL-64(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/11/05 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/11 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/10 |
SUPPL-58(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/04 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/25 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/16 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/07/17 |
SUPPL-56(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2013/12/23 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/23 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/19 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/08/02 |
SUPPL-51(补充) |
Approval |
REMS |
|
|
|
2011/07/25 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/05/17 |
SUPPL-49(补充) |
Approval |
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 |
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) |
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 |
STANDARD
|
|
|
2000/10/11 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/10/11 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/10/11 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/08/04 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1999/04/06 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
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) |
STANDARD
|
|
|
1998/11/30 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/12/16 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/12/16 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/10/04 |
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)
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 | RLD | RS | TE 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
|
ANCHEN PHARMS |
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 |
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 | RLD | RS | TE 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 |
Prescription |
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
|
ANCHEN PHARMS |
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 |
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 | RLD | RS | TE 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 |
Prescription |
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
|
ANCHEN PHARMS |
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 |