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 |
|---|
| 2023/08/18 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/09/20 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/14 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/04 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/07/17 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/18 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/09/19 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/04/07 |
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:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 076690 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2006/08/03
|
TEVA |
| 077653 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
ZYDUS PHARMS USA |
| 078301 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
DR REDDYS LABS LTD |
| 078627 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
SUN PHARM INDS INC |
| 078554 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2009/01/09
|
HERITAGE PHARMS |
| 090555 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2010/04/07
|
AUROBINDO PHARMA |
| 079098 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2010/05/11
|
AMNEAL PHARMS |
| 078932 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2010/12/14
|
ALEMBIC PHARMS LTD |
| 202036 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2015/05/28
|
YAOPHARMA CO LTD |
| 206250 |
001 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2018/11/21
|
CADILA PHARMS LTD |
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 37.5MG 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 |
|---|
| 076690 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2006/08/03
|
TEVA |
| 077653 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
ZYDUS PHARMS USA |
| 078301 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
DR REDDYS LABS LTD |
| 078627 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
SUN PHARM INDS INC |
| 078554 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2009/01/09
|
HERITAGE PHARMS |
| 090555 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2010/04/07
|
AUROBINDO PHARMA |
| 079098 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2010/05/11
|
AMNEAL PHARMS |
| 078932 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2010/12/14
|
ALEMBIC PHARMS LTD |
| 202036 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2015/05/28
|
YAOPHARMA CO LTD |
| 206250 |
002 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2018/11/21
|
CADILA PHARMS LTD |
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 50MG 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 |
|---|
| 076690 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
Yes |
AB |
2006/08/03
|
TEVA |
| 077653 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
ZYDUS PHARMS USA |
| 078301 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
DR REDDYS LABS LTD |
| 078627 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
SUN PHARM INDS INC |
| 078554 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2009/01/09
|
HERITAGE PHARMS |
| 090555 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2010/04/07
|
AUROBINDO PHARMA |
| 079098 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2010/05/11
|
AMNEAL PHARMS |
| 078932 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2010/12/14
|
ALEMBIC PHARMS LTD |
| 202036 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2015/05/28
|
YAOPHARMA CO LTD |
| 206250 |
003 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2018/11/21
|
CADILA PHARMS LTD |
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 75MG 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 |
|---|
| 076690 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2006/08/03
|
TEVA |
| 077653 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
ZYDUS PHARMS USA |
| 078301 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
DR REDDYS LABS LTD |
| 078627 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
SUN PHARM INDS INC |
| 078554 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2009/01/09
|
HERITAGE PHARMS |
| 090555 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2010/04/07
|
AUROBINDO PHARMA |
| 079098 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2010/05/11
|
AMNEAL PHARMS |
| 078932 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2010/12/14
|
ALEMBIC PHARMS LTD |
| 202036 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2015/05/28
|
YAOPHARMA CO LTD |
| 206250 |
004 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2018/11/21
|
CADILA PHARMS LTD |
活性成分:VENLAFAXINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 100MG 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 |
|---|
| 076690 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2006/08/03
|
TEVA |
| 077653 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
ZYDUS PHARMS USA |
| 078301 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
DR REDDYS LABS LTD |
| 078627 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2008/06/13
|
SUN PHARM INDS INC |
| 078554 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2009/01/09
|
HERITAGE PHARMS |
| 090555 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2010/04/07
|
AUROBINDO PHARMA |
| 079098 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2010/05/11
|
AMNEAL PHARMS |
| 078932 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2010/12/14
|
ALEMBIC PHARMS LTD |
| 202036 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2015/05/28
|
YAOPHARMA CO LTD |
| 206250 |
005 |
ANDA |
VENLAFAXINE HYDROCHLORIDE |
VENLAFAXINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2018/11/21
|
CADILA PHARMS LTD |