美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA021290"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
66215-102-06 66215-102 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 N/A NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 125 mg/1 1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
66215-102-03 66215-102 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20121002 N/A NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 125 mg/1 10 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
66215-101-06 66215-101 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 N/A NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 62.5 mg/1 1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
66215-101-03 66215-101 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20121002 N/A NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 62.5 mg/1 10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
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