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 |
2024/05/07 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/08/18 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/06/30 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/06/30 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/10 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/10 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/16 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/09 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
2011/11/22 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
2010/06/25 |
SUPPL-7(补充) |
Approval |
REMS |
|
|
|
2010/01/25 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
2008/09/23 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
2008/03/12 |
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:AB2
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 |
075914 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2004/05/27
|
IMPAX LABS |
077475 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2008/03/12
|
SANDOZ |
079094 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
Yes |
AB2 |
2009/03/24
|
ACTAVIS LABS FL INC |
091520 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Discontinued |
No |
No |
AB2 |
2011/06/09
|
ENDO OPERATIONS |
206122 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2016/08/17
|
SCIEGEN PHARMS INC |
216766 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Prescription |
No |
No |
AB2 |
2023/01/09
|
YICHANG HUMANWELL |