| 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 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | No | No | AP | 2020/06/03 | 2020/06/03 | Prescription |
| 002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | No | No | AP | 2020/06/03 | 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 |
|---|---|---|---|---|---|---|
| 2020/06/03 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 021038 | 002 | NDA | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | Yes | Yes | AP | 2013/03/13 | HOSPIRA |
| 208532 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2018/08/21 | BAXTER HLTHCARE CORP |
| 208129 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2018/11/29 | FRESENIUS KABI USA |
| 212791 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2019/12/04 | WILSHIRE PHARMS INC |
| 206407 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/01/30 | HIKMA |
| 207551 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/05/20 | AMNEAL PHARMS CO |
| 209307 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/06/03 | GLAND PHARMA LTD |
| 209065 | 003 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/06/12 | HENGRUI PHARMA |
| 212571 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/08/27 | MYLAN LABS LTD |
| 208266 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/09/15 | ENDO OPERATIONS |
| 212857 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/11/23 | TAGI |
| 210321 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/12/07 | EUGIA PHARMA |
| 216604 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2023/05/15 | AMNEAL |
| 217308 | 001 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2023/06/07 | MILLA PHARMS |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 021038 | 003 | NDA | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | Yes | Yes | AP | 2013/03/13 | HOSPIRA |
| 208532 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2018/08/21 | BAXTER HLTHCARE CORP |
| 208129 | 003 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2018/11/29 | FRESENIUS KABI USA |
| 212791 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2019/12/04 | WILSHIRE PHARMS INC |
| 206407 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/01/30 | HIKMA |
| 207551 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/05/20 | AMNEAL PHARMS CO |
| 209307 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/06/03 | GLAND PHARMA LTD |
| 209065 | 004 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/06/12 | HENGRUI PHARMA |
| 212571 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/08/27 | MYLAN LABS LTD |
| 208266 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/09/15 | ENDO OPERATIONS |
| 212857 | 003 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/11/23 | TAGI |
| 210321 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2020/12/07 | EUGIA PHARMA |
| 216604 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2023/05/15 | AMNEAL |
| 217308 | 002 | ANDA | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | Prescription | No | No | AP | 2023/06/07 | MILLA PHARMS |