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=NDA213491"
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
75987-140-13 75987-140 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate GRANULE, DELAYED RELEASE ORAL 20200214 N/A NDA NDA213491 Horizon Therapeutics USA, Inc. CYSTEAMINE BITARTRATE 75 mg/1 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
75987-140-14 75987-140 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate GRANULE, DELAYED RELEASE ORAL 20200214 N/A NDA NDA213491 Horizon Therapeutics USA, Inc. CYSTEAMINE BITARTRATE 75 mg/1 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
75987-145-13 75987-145 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate GRANULE, DELAYED RELEASE ORAL 20200214 N/A NDA NDA213491 Horizon Therapeutics USA, Inc. CYSTEAMINE BITARTRATE 300 mg/1 60 PACKET in 1 CARTON (75987-145-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
75987-145-14 75987-145 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate GRANULE, DELAYED RELEASE ORAL 20200214 N/A NDA NDA213491 Horizon Therapeutics USA, Inc. CYSTEAMINE BITARTRATE 300 mg/1 120 PACKET in 1 CARTON (75987-145-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET
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