美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DEXMEDETOMIDINE HYDROCHLORIDE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
DEXMEDETOMIDINE HYDROCHLORIDE 202881 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2014/08/18 2014/08/18 MYLAN INSTITUTIONAL Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 203972 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2014/08/18 2014/08/18 PAR STERILE PRODUCTS Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 202585 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2014/11/24 2014/11/24 AKORN INC Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 202126 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2015/08/20 2015/08/20 SUN PHARM INDS INC Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 201072 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2015/09/18 2015/09/18 FRESENIUS KABI USA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 206628 001 NDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) Yes No 2015/10/21 2015/10/21 HQ SPCLT PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 206628 002 NDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) Yes Yes 2015/10/21 2015/10/21 HQ SPCLT PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 206628 003 NDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) Yes No 2015/10/21 2018/06/22 HQ SPCLT PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 206628 004 NDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) Yes No 2015/10/21 2018/06/22 HQ SPCLT PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 204023 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2016/02/09 2016/02/09 ACCORD HLTHCARE Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 205867 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2016/03/17 2016/03/17 AUROBINDO PHARMA LTD Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 091465 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2016/06/14 2016/06/14 SANDOZ INC Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 204686 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2016/10/17 2016/10/17 ACTAVIS INC Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 205046 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2017/04/26 2017/04/26 WEST-WARD PHARMS INT Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 203773 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2017/05/12 2017/05/12 AM REGENT Discontinued
DEXMEDETOMIDINE HYDROCHLORIDE 209065 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2017/09/19 2017/09/19 JIANGSU HENGRUI MED Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 205272 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2017/11/28 2017/11/28 TEVA PHARMS USA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 206798 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2018/02/27 2018/02/27 ZYDUS PHARMS Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 207551 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No 2018/03/29 (TA) AMNEAL PHARMS CO None (Tentative Approval)
DEXMEDETOMIDINE HYDROCHLORIDE 208532 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 2018/08/21 2018/08/21 BAXTER HLTHCARE CORP Prescription
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