美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=EDEX"
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
KERLEDEX 019807 001 NDA BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE TABLET;ORAL 5MG;12.5MG No No 1992/10/30 1992/10/30 SANOFI AVENTIS US Discontinued
KERLEDEX 019807 002 NDA BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE TABLET;ORAL 10MG;12.5MG No No 1992/10/30 1992/10/30 SANOFI AVENTIS US Discontinued
EDEX 020649 001 NDA ALPROSTADIL INJECTABLE;INJECTION 0.005MG/VIAL No No 1997/06/12 1997/06/12 AUXILIUM PHARMS LLC Discontinued
EDEX 020649 002 NDA ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes No 1997/06/12 1997/06/12 AUXILIUM PHARMS LLC Prescription
EDEX 020649 003 NDA ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes No 1997/06/12 1997/06/12 AUXILIUM PHARMS LLC Prescription
EDEX 020649 004 NDA ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes 1997/06/12 1997/06/12 AUXILIUM PHARMS LLC Prescription
EDEX 020649 005 NDA ALPROSTADIL INJECTABLE;INJECTION 0.01MG/VIAL Yes Yes 1997/06/12 1998/07/30 AUXILIUM PHARMS LLC Prescription
EDEX 020649 006 NDA ALPROSTADIL INJECTABLE;INJECTION 0.02MG/VIAL Yes Yes 1997/06/12 1998/07/30 AUXILIUM PHARMS LLC Prescription
EDEX 020649 007 NDA ALPROSTADIL INJECTABLE;INJECTION 0.04MG/VIAL Yes Yes 1997/06/12 1998/07/30 AUXILIUM PHARMS LLC Prescription
PRECEDEX 021038 001 NDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Yes Yes 1999/12/17 1999/12/17 HOSPIRA Prescription
PRECEDEX 021038 002 NDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) Yes Yes 1999/12/17 2013/03/13 HOSPIRA Prescription
PRECEDEX 021038 003 NDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) Yes Yes 1999/12/17 2013/03/13 HOSPIRA Prescription
PRECEDEX 021038 004 NDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) Yes Yes 1999/12/17 2014/11/14 HOSPIRA Prescription
NUEDEXTA 021879 001 NDA DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE CAPSULE;ORAL 20MG;10MG Yes Yes 2010/10/29 2010/10/29 AVANIR PHARMS Prescription
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