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=NDA213378"
符合检索条件的记录共 16 条，共 1 页，当前第 1 页 ，可点击列名称排序
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
65757-651-42 65757-651 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 5 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE
65757-651-44 65757-651 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 5 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-651-44) / 90 TABLET, FILM COATED in 1 BOTTLE
65757-652-40 65757-652 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 10 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-652-40) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-652-41 65757-652 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 10 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-652-41) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-652-42 65757-652 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 10 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-652-42) / 30 TABLET, FILM COATED in 1 BOTTLE
65757-652-44 65757-652 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 10 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-652-44) / 90 TABLET, FILM COATED in 1 BOTTLE
65757-653-40 65757-653 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 15 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-653-40) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-653-41 65757-653 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 15 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-653-41) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-653-42 65757-653 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 15 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-653-42) / 30 TABLET, FILM COATED in 1 BOTTLE
65757-653-44 65757-653 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 15 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-653-44) / 90 TABLET, FILM COATED in 1 BOTTLE
65757-654-40 65757-654 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 20 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-654-40) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-654-41 65757-654 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 20 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-654-41) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-654-42 65757-654 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 20 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-654-42) / 30 TABLET, FILM COATED in 1 BOTTLE
65757-654-44 65757-654 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 20 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-654-44) / 90 TABLET, FILM COATED in 1 BOTTLE
65757-651-41 65757-651 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 5 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE
65757-651-40 65757-651 HUMAN PRESCRIPTION DRUG LYBALVI olanzapine and samidorphan L-malate TABLET, FILM COATED ORAL 20210920 N/A NDA NDA213378 Alkermes, Inc. OLANZAPINE; SAMIDORPHAN L-MALATE 5 mg/1; 10 mg/1 1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE
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