| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No | AB | 2021/06/30 | 2021/06/30 | Prescription |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | No | No | AB | 2021/06/30 | Prescription |
| 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 |
|---|---|---|---|---|---|---|
| 2024/04/09 | SUPPL-2（补充） | Approval | Labeling | STANDARD | ||
| 2021/06/30 | ORIG-1（原始申请） | Approval | STANDARD |
| 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 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 022104 | 003 | NDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | Yes | Yes | AB | 2008/05/20 | OSMOTICA PHARM US |
| 091272 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Discontinued | No | No | AB | 2010/08/18 | SUN PHARM |
| 205468 | 002 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2017/03/24 | NOSTRUM LABS INC |
| 211323 | 002 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2019/08/29 | CADILA PHARMS LTD |
| 209193 | 001 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2019/10/31 | DEXCEL |
| 214419 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2020/10/21 | ASCENT PHARMS INC |
| 214127 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2021/06/10 | ALKEM LABS LTD |
| 214609 | 001 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2021/06/30 | APPCO |
| 214423 | 002 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Discontinued | No | No | AB | 2022/01/04 | SWISS PHARM |
| 215622 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2022/08/30 | ZYDUS PHARMS |
| 216044 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2022/11/28 | UNIQUE |
| 214691 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | No | No | AB | 2023/04/12 | AJANTA PHARMA LTD |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 022104 | 004 | NDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | Yes | No | AB | 2008/05/20 | OSMOTICA PHARM US |
| 205468 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2017/03/24 | NOSTRUM LABS INC |
| 091272 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Discontinued | No | No | AB | 2019/01/08 | SUN PHARM |
| 211323 | 003 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2019/08/29 | CADILA PHARMS LTD |
| 209193 | 002 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2019/10/31 | DEXCEL |
| 214419 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2020/10/21 | ASCENT PHARMS INC |
| 214127 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2021/06/10 | ALKEM LABS LTD |
| 214609 | 002 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2021/06/30 | APPCO |
| 215622 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2022/08/30 | ZYDUS PHARMS |
| 216044 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2022/11/28 | UNIQUE |
| 214691 | 004 | ANDA | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | Prescription | No | No | AB | 2023/04/12 | AJANTA PHARMA LTD |