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=ANDA040621"
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
53002-1501-0 53002-1501 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20170901 N/A ANDA ANDA040621 RPK Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-0)
53002-1501-3 53002-1501 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20170901 N/A ANDA ANDA040621 RPK Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-3)
63187-891-30 63187-891 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20170801 N/A ANDA ANDA040621 Proficient Rx LP PHENYTOIN SODIUM 100 mg/1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-30)
63187-891-60 63187-891 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20170801 N/A ANDA ANDA040621 Proficient Rx LP PHENYTOIN SODIUM 100 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-60)
63187-891-90 63187-891 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20170801 N/A ANDA ANDA040621 Proficient Rx LP PHENYTOIN SODIUM 100 mg/1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-90)
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