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=NDA207999"
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
69516-005-30 69516-005 HUMAN PRESCRIPTION DRUG Ocaliva Obeticholic Acid TABLET, FILM COATED ORAL 20160527 N/A NDA NDA207999 Intercept Pharmaceuticals Inc OBETICHOLIC ACID 5 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30)
69516-010-30 69516-010 HUMAN PRESCRIPTION DRUG Ocaliva Obeticholic Acid TABLET, FILM COATED ORAL 20160527 N/A NDA NDA207999 Intercept Pharmaceuticals Inc OBETICHOLIC ACID 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-010-30)
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