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 |
|---|
| 2024/01/16 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/02 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/02 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/24 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/10/21 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 2011/10/21 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 2010/08/02 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 2010/05/24 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2010/05/10 |
SUPPL-17（补充） |
Approval |
REMS |
|
|
|
| 2010/04/05 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 2004/03/22 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2004/03/22 |
SUPPL-2（补充） |
Approval |
Supplement |
|
|
|
| 2004/03/22 |
SUPPL-1（补充） |
Approval |
Supplement |
|
|
|
| 2004/01/28 |
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: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
|
ENDO OPERATIONS |
| 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 |
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 |
Discontinued |
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
|
ENDO OPERATIONS |
| 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 |
