美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TOBI"
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
OTOBIONE 061816 001 ANDA HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE SUSPENSION/DROPS;OTIC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML No No -- Approved Prior to Jan 1, 1982 SCHERING Discontinued
ERYTHROMYCIN LACTOBIONATE 062604 001 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No -- 1986/11/24 ABRAXIS PHARM Discontinued
ERYTHROMYCIN LACTOBIONATE 062604 002 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No -- 1986/11/24 ABRAXIS PHARM Discontinued
ERYTHROMYCIN LACTOBIONATE 062660 001 ANDA ERYTHROMYCIN LACTOBIONATE Injectable; Injection EQ 500MG BASE/VIAL No -- QUAD PHARMS Discontinued
ERYTHROMYCIN LACTOBIONATE 062660 003 ANDA ERYTHROMYCIN LACTOBIONATE Injectable; Injection EQ 1GM BASE/VIAL No -- QUAD PHARMS Discontinued
OTOBIOTIC 062302 001 ANDA HYDROCORTISONE; POLYMYXIN B SULFATE SOLUTION/DROPS;OTIC 5MG/ML;EQ 10,000 UNITS BASE/ML No No 1981/12/01 Approved Prior to Jan 1, 1982 SCHERING Discontinued
ERYTHROMYCIN LACTOBIONATE 062993 001 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 1989/05/09 1989/05/09 BAXTER HLTHCARE Discontinued
ERYTHROMYCIN LACTOBIONATE 062993 002 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1989/05/09 1989/05/09 BAXTER HLTHCARE Discontinued
ERYTHROMYCIN LACTOBIONATE 063253 001 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 1993/07/30 1993/07/30 TEVA PARENTERAL Discontinued
ERYTHROMYCIN LACTOBIONATE 063253 002 ANDA ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 1993/07/30 1993/07/30 TEVA PARENTERAL Discontinued
TOBI 050753 001 NDA TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Yes Yes 1997/12/22 1997/12/22 MYLAN SPECIALITY LP Prescription
TOBI PODHALER 201688 001 NDA TOBRAMYCIN POWDER;INHALATION 28MG Yes Yes 2013/03/22 2013/03/22 MYLAN SPECIALITY LP Prescription
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