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=NDA021196"
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
68727-100-01 68727-100 HUMAN PRESCRIPTION DRUG Xyrem sodium oxybate SOLUTION ORAL 20020717 N/A NDA NDA021196 Jazz Pharmaceuticals, Inc. SODIUM OXYBATE .5 g/mL 180 mL in 1 BOTTLE, PLASTIC (68727-100-01)
0054-9628-57 0054-9628 HUMAN PRESCRIPTION DRUG sodium oxybate sodium oxybate SOLUTION ORAL 20230103 N/A NDA AUTHORIZED GENERIC NDA021196 Hikma Pharmaceuticals USA Inc. SODIUM OXYBATE .5 g/mL 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)
69238-2391-1 69238-2391 HUMAN PRESCRIPTION DRUG sodium oxybate sodium oxybate SOLUTION ORAL 20230703 N/A NDA AUTHORIZED GENERIC NDA021196 Amneal Pharmaceuticals NY LLC SODIUM OXYBATE .5 g/mL 180 mL in 1 BOTTLE, PLASTIC (69238-2391-1)
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