药品注册申请号：021038
申请类型：NDA (新药申请)
申请人：HOSPIRA
申请人全名：HOSPIRA INC
产品信息
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 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Yes Yes AP 1999/12/17 1999/12/17 Prescription
002 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) Yes Yes AP 2013/03/13 Prescription
003 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) Yes Yes AP 2013/03/13 Prescription
004 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Yes Yes AP 2014/11/14 Prescription
005 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) Yes Yes None 2020/01/31 Prescription
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
2024/04/15 SUPPL-55（补充） Approval UNKNOWN
2022/12/16 SUPPL-28（补充） Approval Efficacy STANDARD
2022/08/12 SUPPL-33（补充） Approval Labeling STANDARD
2022/08/12 SUPPL-31（补充） Approval Labeling STANDARD
2020/01/31 SUPPL-35（补充） Approval Manufacturing (CMC) N/A
2016/04/11 SUPPL-27（补充） Approval Labeling STANDARD
2014/11/14 SUPPL-26（补充） Approval Labeling STANDARD
2014/11/14 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
2014/11/14 SUPPL-19（补充） Approval Labeling STANDARD
2014/04/18 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2014/01/16 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2013/09/28 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2013/06/17 SUPPL-22（补充） Approval Efficacy PRIORITY
2013/06/17 SUPPL-21（补充） Approval Efficacy PRIORITY
2013/03/13 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2010/10/13 SUPPL-17（补充） Approval Labeling UNKNOWN
2008/10/17 SUPPL-10（补充） Approval Efficacy UNKNOWN
2001/05/08 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2001/01/16 SUPPL-1（补充） Approval Labeling STANDARD
1999/12/17 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
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
002 10016396 2032/01/04 Y 2018/08/09 PDF格式
8242158 2032/01/04 Y 2013/05/21 PDF格式
8242158*PED 2032/07/04 PDF格式
8338470 2032/01/04 Y 2013/05/21 PDF格式
8338470*PED 2032/07/04 PDF格式
8455527 2032/01/04 U-421 PDF格式
8455527*PED 2032/07/04 PDF格式
8648106 2032/01/04 Y 2014/03/05 PDF格式
8648106*PED 2032/07/04 PDF格式
9320712 2032/01/04 Y 2016/09/19 PDF格式
9320712*PED 2032/07/04 PDF格式
9616049 2032/01/04 Y 2017/05/09 PDF格式
9616049*PED 2032/07/04 PDF格式
003 10016396 2032/01/04 Y 2018/08/09 PDF格式
8242158 2032/01/04 Y PDF格式
8242158*PED 2032/07/04 PDF格式
8338470 2032/01/04 Y PDF格式
8338470*PED 2032/07/04 PDF格式
8455527 2032/01/04 U-421 PDF格式
8455527*PED 2032/07/04 PDF格式
8648106 2032/01/04 Y 2014/03/05 PDF格式
8648106*PED 2032/07/04 PDF格式
9320712 2032/01/04 Y 2016/09/19 PDF格式
9320712*PED 2032/07/04 PDF格式
9616049 2032/01/04 Y 2017/05/09 PDF格式
9616049*PED 2032/07/04 PDF格式
004 8242158 2032/01/04 Y 2015/01/30 PDF格式
8242158*PED 2032/07/04 PDF格式
8338470 2032/01/04 Y 2015/01/30 PDF格式
8338470*PED 2032/07/04 PDF格式
8455527 2032/01/04 U-421 2015/01/30 PDF格式
8455527*PED 2032/07/04 PDF格式
8648106 2032/01/04 Y 2015/01/30 PDF格式
8648106*PED 2032/07/04 PDF格式
9320712 2032/01/04 Y 2016/09/19 PDF格式
9320712*PED 2032/07/04 PDF格式
9616049 2032/01/04 Y 2017/05/09 PDF格式
9616049*PED 2032/07/04 PDF格式
001 4910214 2013/07/15 Y Y U-421 PDF格式**本条是由Drugfuture回溯的历史信息**
4910214*PED 2014/01/15 PDF格式**本条是由Drugfuture回溯的历史信息**
5344840 2011/09/06 U-912 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867 2019/03/31 U-1472 U-572 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867*PED 2019/10/01 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4910214 2013/07/15 Y Y U-421 PDF格式**本条是由Drugfuture回溯的历史信息**
4910214*PED 2014/01/15 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867 2019/03/31 U-1472 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867*PED 2019/10/01 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4910214 2013/07/15 Y Y U-421 PDF格式**本条是由Drugfuture回溯的历史信息**
4910214*PED 2014/01/15 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867 2019/03/31 U-1472 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867*PED 2019/10/01 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6716867 2019/03/31 U-1472 PDF格式**本条是由Drugfuture回溯的历史信息**
6716867*PED 2019/10/01 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 NPP 2025/12/16
002 NPP 2025/12/16
003 NPP 2025/12/16
004 NPP 2025/12/16
005 NPP 2025/12/16
001 I-577 2011/10/17**本条是由Drugfuture回溯的历史信息**
M-61 2016/06/17**本条是由Drugfuture回溯的历史信息**
PED 2016/12/17**本条是由Drugfuture回溯的历史信息**
002 M-61 2016/06/17**本条是由Drugfuture回溯的历史信息**
PED 2016/12/17**本条是由Drugfuture回溯的历史信息**
003 M-61 2016/06/17**本条是由Drugfuture回溯的历史信息**
PED 2016/12/17**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:DEXMEDETOMIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) 治疗等效代码:AP
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RLDRSTE Code产品号批准日期申请人
021038 001 NDA PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription Yes Yes AP 1999/12/17 HOSPIRA
202881 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/08/18 MYLAN INSTITUTIONAL
203972 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/08/18 ENDO OPERATIONS
202585 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/11/24 RISING
202126 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2015/08/20 GLAND
201072 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2015/09/18 FRESENIUS KABI USA
204023 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/02/09 ACCORD HLTHCARE
205867 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/03/17 EUGIA PHARMA
091465 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/06/14 SANDOZ
204686 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/10/17 ACTAVIS INC
205046 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/04/26 HIKMA
209065 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/09/19 HENGRUI PHARMA
205272 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/11/28 TEVA PHARMS USA
206798 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2018/02/27 ZYDUS PHARMS
204843 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2019/01/18 MEITHEAL
活性成分:DEXMEDETOMIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) 治疗等效代码:AP
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RLDRSTE 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
活性成分:DEXMEDETOMIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) 治疗等效代码:AP
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RLDRSTE 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
活性成分:DEXMEDETOMIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) 治疗等效代码:AP
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RLDRSTE Code产品号批准日期申请人
021038 004 NDA PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Prescription Yes Yes AP 2014/11/14 HOSPIRA
208129 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Prescription No No AP 2018/11/29 FRESENIUS KABI USA
209065 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Prescription No No AP 2020/06/12 HENGRUI PHARMA
212857 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Prescription No No AP 2020/11/23 TAGI
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