美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ZOFRAN"
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
ZOFRAN 020007 001 NDA ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1991/01/04 1991/01/04 NOVARTIS PHARMS CORP Discontinued
ZOFRAN PRESERVATIVE FREE 020007 003 NDA ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1991/01/04 1993/12/10 NOVARTIS PHARMS CORP Discontinued
ZOFRAN 020103 001 NDA ONDANSETRON HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Yes No 1992/12/31 1992/12/31 NOVARTIS PHARMS CORP Prescription
ZOFRAN 020103 002 NDA ONDANSETRON HYDROCHLORIDE TABLET;ORAL EQ 8MG BASE Yes No 1992/12/31 1992/12/31 NOVARTIS PHARMS CORP Prescription
ZOFRAN 020103 003 NDA ONDANSETRON HYDROCHLORIDE TABLET;ORAL EQ 24MG BASE Yes Yes 1992/12/31 1999/08/27 NOVARTIS PHARMS CORP Prescription
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER 020403 001 NDA ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1995/01/31 1995/01/31 GLAXOSMITHKLINE Discontinued
ZOFRAN 020605 001 NDA ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Yes Yes 1997/01/24 1997/01/24 NOVARTIS PHARMS CORP Prescription
ZOFRAN ODT 020781 001 NDA ONDANSETRON TABLET, ORALLY DISINTEGRATING;ORAL 4MG Yes No 1999/01/27 1999/01/27 NOVARTIS PHARMS CORP Prescription
ZOFRAN ODT 020781 002 NDA ONDANSETRON TABLET, ORALLY DISINTEGRATING;ORAL 8MG Yes Yes 1999/01/27 1999/01/27 NOVARTIS PHARMS CORP Prescription
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