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
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/04/11 SUPPL 27 Approval Labeling STANDARD
2014/11/14 SUPPL 26 Approval Labeling STANDARD
2014/11/14 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2014/11/14 SUPPL 19 Approval Labeling STANDARD
2014/04/18 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2014/01/16 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2013/09/28 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2013/06/17 SUPPL 22 Approval Efficacy PRIORITY
2013/06/17 SUPPL 21 Approval Efficacy PRIORITY
2013/03/13 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2010/10/13 SUPPL 17 Approval Labeling UNKNOWN
2008/10/17 SUPPL 10 Approval Efficacy UNKNOWN
2001/05/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/01/16 SUPPL 1 Approval Labeling STANDARD
1999/12/17 ORIG 1 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
001 6716867 2019/03/31 U-1472 PDF格式
6716867*PED 2019/10/01 PDF格式
002 10016396 2032/01/04 Y 2018/08/09 PDF格式
6716867 2019/03/31 U-1472 PDF格式
6716867*PED 2019/10/01 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
6716867 2019/03/31 U-1472 PDF格式
6716867*PED 2019/10/01 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 6716867 2019/03/31 U-1472 2015/01/30 PDF格式
6716867*PED 2019/10/01 PDF格式
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**
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**
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**
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 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 PAR STERILE PRODUCTS
202585 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/11/24 AKORN INC
202126 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2015/08/20 SUN PHARM INDS INC
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 AUROBINDO PHARMA LTD
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 INC
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 WEST-WARD PHARMS INT
209065 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/09/19 JIANGSU HENGRUI MED
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
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
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
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
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