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=NDA022301"
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
68682-113-20 68682-113 HUMAN PRESCRIPTION DRUG mesalamine mesalamine CAPSULE, EXTENDED RELEASE ORAL 20180719 N/A NDA AUTHORIZED GENERIC NDA022301 Oceanside Pharmaceuticals MESALAMINE 375 mg/1 1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
65649-103-01 65649-103 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20081031 N/A NDA NDA022301 Salix Pharmaceuticals, Inc. MESALAMINE 375 mg/1 1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
65649-103-02 65649-103 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20081031 N/A NDA NDA022301 Salix Pharmaceuticals, Inc. MESALAMINE 375 mg/1 1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
0093-9224-89 0093-9224 HUMAN PRESCRIPTION DRUG mesalamine mesalamine CAPSULE, EXTENDED RELEASE ORAL 20210105 N/A NDA AUTHORIZED GENERIC NDA022301 Teva Pharmaceuticals USA, Inc. MESALAMINE 375 mg/1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)
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