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-54（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/08/02 |
SUPPL-52（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/08/02 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/06/12 |
SUPPL-42（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/25 |
SUPPL-39（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/25 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/25 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/12/13 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/10/31 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 2011/08/30 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 2011/01/25 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2011/01/20 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 2010/11/19 |
SUPPL-20（补充） |
Approval |
REMS |
|
|
|
| 2009/12/15 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2007/09/17 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2006/12/14 |
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:300MG 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 |
002 |
NDA |
WELLBUTRIN XL |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
Yes |
Yes |
AB3 |
2003/08/28
|
BAUSCH |
| 077284 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB3 |
2006/12/14
|
ANCHEN PHARMS |
| 077285 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2008/08/15
|
WATSON LABS INC |
| 201567 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2014/01/17
|
ZYDUS PHARMS |
| 206556 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB3 |
2016/08/26
|
INVAGEN PHARMS |
| 090693 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/04/06
|
LUPIN LTD |
| 207479 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/04/12
|
SCIEGEN PHARMS INC |
| 207224 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/06/30
|
ANBISON LAB |
| 208652 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/08/21
|
SINOTHERAPEUTICS INC |
| 210081 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/11/03
|
TWI PHARMS |
| 210015 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2018/06/14
|
YICHANG HUMANWELL |
| 210497 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2018/10/31
|
ACCORD HLTHCARE |
| 211020 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2019/01/28
|
GRAVITI PHARMS |
| 211200 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2019/09/05
|
ZHEJIANG JUTAI PHARM |
| 203650 |
001 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2020/12/31
|
SUN PHARM |
| 202189 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2022/01/28
|
WOCKHARDT LTD |
| 215568 |
002 |
ANDA |
BUPROPION HYDROCHLORIDE |
BUPROPION HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2022/02/02
|
GRANULES |
