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 |
|---|
| 2021/05/04 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/05/04 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/07/15 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/12/27 |
SUPPL-20（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/12/27 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 2011/07/27 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 2011/06/24 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2010/08/18 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 2010/07/02 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 2009/07/22 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/17 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2008/03/26 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2007/06/29 |
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:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 12.5MG BASE 治疗等效代码:AB
| 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 |
|---|
| 020936 |
001 |
NDA |
PAXIL CR |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
Yes |
No |
AB |
1999/02/16
|
APOTEX |
| 077873 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2007/06/29
|
AUROBINDO PHARMA USA |
| 204744 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2016/06/10
|
LANNETT CO INC |
| 204134 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2017/01/20
|
LUPIN LTD |
| 209293 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2018/06/12
|
SCIECURE PHARMA INC |
| 213485 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2021/02/16
|
CSPC OUYI |
| 212645 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2021/08/27
|
CADILA PHARMS LTD |
| 209748 |
001 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2024/01/04
|
PRINSTON INC |
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 25MG BASE 治疗等效代码:AB
| 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 |
|---|
| 020936 |
002 |
NDA |
PAXIL CR |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
Yes |
No |
AB |
1999/02/16
|
APOTEX |
| 077873 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2007/06/29
|
AUROBINDO PHARMA USA |
| 204744 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2016/06/10
|
LANNETT CO INC |
| 204134 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2017/01/20
|
LUPIN LTD |
| 209293 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2018/06/12
|
SCIECURE PHARMA INC |
| 213485 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/02/16
|
CSPC OUYI |
| 212645 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/08/27
|
CADILA PHARMS LTD |
| 209748 |
002 |
ANDA |
PAROXETINE HYDROCHLORIDE |
PAROXETINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2024/01/04
|
PRINSTON INC |
