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=NDA215422"
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
70257-412-87 70257-412 HUMAN PRESCRIPTION DRUG Lyvispah baclofen GRANULE ORAL 20211122 N/A NDA NDA215422 Saol Therapeutics Inc BACLOFEN 5 mg/1 90 PACKET in 1 BOTTLE, UNIT-DOSE (70257-412-87) / 1 GRANULE in 1 PACKET
70257-414-87 70257-414 HUMAN PRESCRIPTION DRUG Lyvispah baclofen GRANULE ORAL 20211122 N/A NDA NDA215422 Saol Therapeutics Inc BACLOFEN 10 mg/1 90 PACKET in 1 BOTTLE, UNIT-DOSE (70257-414-87) / 1 GRANULE in 1 PACKET
70257-416-87 70257-416 HUMAN PRESCRIPTION DRUG Lyvispah baclofen GRANULE ORAL 20211122 N/A NDA NDA215422 Saol Therapeutics Inc BACLOFEN 20 mg/1 90 PACKET in 1 BOTTLE, UNIT-DOSE (70257-416-87) / 1 GRANULE in 1 PACKET
64896-076-09 64896-076 HUMAN PRESCRIPTION DRUG LYVISPAH baclofen GRANULE ORAL 20230601 N/A NDA NDA215422 Amneal Pharmaceuticals LLC BACLOFEN 5 mg/1 90 PACKET in 1 CARTON (64896-076-09) / 1 GRANULE in 1 PACKET
64896-077-09 64896-077 HUMAN PRESCRIPTION DRUG LYVISPAH baclofen GRANULE ORAL 20230601 N/A NDA NDA215422 Amneal Pharmaceuticals LLC BACLOFEN 10 mg/1 90 PACKET in 1 CARTON (64896-077-09) / 1 GRANULE in 1 PACKET
64896-078-09 64896-078 HUMAN PRESCRIPTION DRUG LYVISPAH baclofen GRANULE ORAL 20230601 N/A NDA NDA215422 Amneal Pharmaceuticals LLC BACLOFEN 20 mg/1 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET
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