美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ORAPRED"
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
ORAPRED 075117 001 ANDA PREDNISOLONE SODIUM PHOSPHATE SOLUTION;ORAL EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2000/12/14 2000/12/14 CONCORDIA PHARMS INC Discontinued
ORAPRED ODT 021959 001 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE Yes No 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
ORAPRED ODT 021959 002 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 15MG BASE Yes No 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
ORAPRED ODT 021959 003 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 30MG BASE Yes Yes 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
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