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=NDA215390"
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
81092-1120-1 81092-1120 HUMAN PRESCRIPTION DRUG IGALMI DEXMEDETOMIDINE FILM SUBLINGUAL 20220701 N/A NDA NDA215390 BioXcel Therapeutics, Inc. DEXMEDETOMIDINE 120 ug/1 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)
81092-1120-3 81092-1120 HUMAN PRESCRIPTION DRUG IGALMI DEXMEDETOMIDINE FILM SUBLINGUAL 20240701 N/A NDA NDA215390 BioXcel Therapeutics, Inc. DEXMEDETOMIDINE 120 ug/1 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)
81092-1180-1 81092-1180 HUMAN PRESCRIPTION DRUG IGALMI DEXMEDETOMIDINE FILM SUBLINGUAL 20220701 N/A NDA NDA215390 BioXcel Therapeutics, Inc. DEXMEDETOMIDINE 180 ug/1 10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0)
81092-1180-3 81092-1180 HUMAN PRESCRIPTION DRUG IGALMI DEXMEDETOMIDINE FILM SUBLINGUAL 20240701 N/A NDA NDA215390 BioXcel Therapeutics, Inc. DEXMEDETOMIDINE 180 ug/1 30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0)
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