| 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 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No | AB | 2020/06/22 | 2020/06/22 | Discontinued |
| 002 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | No | No | AB | 2020/06/22 | Discontinued | |
| 003 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | No | No | AB | 2020/06/22 | Discontinued |
| 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 |
|---|---|---|---|---|---|---|
| 2020/06/22 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 019906 | 001 | NDA | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | Yes | Yes | AB | 1989/12/29 | SPECGX LLC |
| 074364 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 1996/03/29 | CHARTWELL RX |
| 074694 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 1996/12/31 | TARO |
| 074953 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 1997/06/25 | SANDOZ |
| 074947 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 1998/04/30 | MYLAN |
| 208961 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2017/12/27 | ZYDUS PHARMS |
| 208632 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2018/10/31 | AMNEAL PHARMS CO |
| 209294 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2018/11/21 | LUPIN LTD |
| 211767 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2019/04/08 | MANKIND PHARMA |
| 212218 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2019/10/21 | JUBILANT CADISTA |
| 211364 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2020/02/07 | CHEMISTRY HLTH |
| 210653 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2020/04/03 | TULEX PHARMS INC |
| 213219 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2020/06/22 | MICRO LABS |
| 213221 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Discontinued | No | No | AB | 2020/06/22 | RK PHARMA |
| 212285 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2020/08/07 | UNIQUE |
| 213897 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2020/10/02 | AJANTA PHARMA LTD |
| 211822 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2021/08/04 | ALEMBIC |
| 216440 | 001 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | Prescription | No | No | AB | 2023/03/20 | AUROBINDO PHARMA |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 019906 | 002 | NDA | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | Yes | No | AB | 1989/12/29 | SPECGX LLC |
| 074364 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 1996/03/29 | CHARTWELL RX |
| 074694 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 1996/12/31 | TARO |
| 074953 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 1997/06/25 | SANDOZ |
| 074947 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 1998/04/30 | MYLAN |
| 208961 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2017/12/27 | ZYDUS PHARMS |
| 208632 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2018/10/31 | AMNEAL PHARMS CO |
| 209294 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2018/11/21 | LUPIN LTD |
| 211767 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2019/04/08 | MANKIND PHARMA |
| 212218 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2019/10/21 | JUBILANT CADISTA |
| 211364 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2020/02/07 | CHEMISTRY HLTH |
| 210653 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2020/04/03 | TULEX PHARMS INC |
| 213219 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2020/06/22 | MICRO LABS |
| 213221 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Discontinued | No | No | AB | 2020/06/22 | RK PHARMA |
| 212285 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2020/08/07 | UNIQUE |
| 213897 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2020/10/02 | AJANTA PHARMA LTD |
| 211822 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2021/08/04 | ALEMBIC |
| 216440 | 002 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | Prescription | No | No | AB | 2023/03/20 | AUROBINDO PHARMA |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 019906 | 003 | NDA | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | Yes | No | AB | 1989/12/29 | SPECGX LLC |
| 074364 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 1996/03/29 | CHARTWELL RX |
| 074694 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 1996/12/31 | TARO |
| 074953 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 1997/06/25 | SANDOZ |
| 074947 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 1998/04/30 | MYLAN |
| 208961 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2017/12/27 | ZYDUS PHARMS |
| 208632 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2018/10/31 | AMNEAL PHARMS CO |
| 209294 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2018/11/21 | LUPIN LTD |
| 211767 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2019/04/08 | MANKIND PHARMA |
| 212218 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2019/10/21 | JUBILANT CADISTA |
| 211364 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2020/02/07 | CHEMISTRY HLTH |
| 210653 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2020/04/03 | TULEX PHARMS INC |
| 213219 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2020/06/22 | MICRO LABS |
| 213221 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Discontinued | No | No | AB | 2020/06/22 | RK PHARMA |
| 212285 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2020/08/07 | UNIQUE |
| 213897 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2020/10/02 | AJANTA PHARMA LTD |
| 211822 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2021/08/04 | ALEMBIC |
| 216440 | 003 | ANDA | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | Prescription | No | No | AB | 2023/03/20 | AUROBINDO PHARMA |