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
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)
70748-214-16 70748-214 HUMAN PRESCRIPTION DRUG mesalamine mesalamine CAPSULE, EXTENDED RELEASE ORAL 20200518 20250831 NDA AUTHORIZED GENERIC NDA022301 Lupin Pharmaceuticals, Inc. MESALAMINE 375 mg/1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-214-16)
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
43353-884-79 43353-884 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20140217 N/A NDA NDA022301 Aphena Pharma Solutions - Tennessee, LLC MESALAMINE 375 mg/1 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79)
63629-8827-1 63629-8827 HUMAN PRESCRIPTION DRUG mesalamine mesalamine CAPSULE, EXTENDED RELEASE ORAL 20210910 N/A NDA AUTHORIZED GENERIC NDA022301 Bryant Ranch Prepack MESALAMINE 375 mg/1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1)
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