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 |
2023/08/02 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/08/02 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/08/02 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/16 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/16 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/20 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/23 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
2010/08/30 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
2010/04/27 |
SUPPL-20(补充) |
Approval |
REMS |
|
|
|
2010/02/04 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
2009/11/09 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
2008/11/26 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2008/11/26 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
2008/07/09 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
2007/06/13 |
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 | RLD | RS | TE 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 |