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=NDA214755"
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
13551-002-30 13551-002 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 6 g/1 30 PACKET in 1 CARTON (13551-002-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-003-07 13551-003 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 7.5 g/1 7 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-003-30 13551-003 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 7.5 g/1 30 PACKET in 1 CARTON (13551-003-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-004-07 13551-004 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 9 g/1 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-002-07 13551-002 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 6 g/1 7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-001-30 13551-001 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 4.5 g/1 30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-001-07 13551-001 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 4.5 g/1 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-004-30 13551-004 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate FOR SUSPENSION, EXTENDED RELEASE ORAL 20230501 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC SODIUM OXYBATE 9 g/1 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
13551-005-01 13551-005 HUMAN PRESCRIPTION DRUG Lumryz sodium oxybate KIT 20241007 N/A NDA NDA214755 Avadel CNS Pharmaceuticals, LLC 1 KIT in 1 CARTON (13551-005-01) * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
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