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=ANDA084349"
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
58151-110-01 58151-110 HUMAN PRESCRIPTION DRUG DILANTIN Extended Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20241206 N/A ANDA ANDA084349 Viatris Specialty LLC PHENYTOIN SODIUM 100 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)
58151-110-88 58151-110 HUMAN PRESCRIPTION DRUG DILANTIN Extended Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20241206 N/A ANDA ANDA084349 Viatris Specialty LLC PHENYTOIN SODIUM 100 mg/1 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)
70518-4185-0 70518-4185 HUMAN PRESCRIPTION DRUG Dilantin Extended Phenytoin Sodium CAPSULE ORAL 20240924 N/A ANDA ANDA084349 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 100 POUCH in 1 BOX (70518-4185-0) / 1 CAPSULE in 1 POUCH (70518-4185-1)
0071-3740-66 0071-3740 HUMAN PRESCRIPTION DRUG Dilantin Extended Phenytoin Sodium CAPSULE ORAL 19760827 N/A ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 30 mg/1 100 CAPSULE in 1 BOTTLE (0071-3740-66)
0071-0369-24 0071-0369 HUMAN PRESCRIPTION DRUG Dilantin Extended Phenytoin Sodium CAPSULE ORAL 19760827 20251130 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 100 mg/1 100 CAPSULE in 1 BOTTLE (0071-0369-24)
0071-0369-32 0071-0369 HUMAN PRESCRIPTION DRUG Dilantin Extended Phenytoin Sodium CAPSULE ORAL 19760827 N/A ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 100 mg/1 1000 CAPSULE in 1 BOTTLE (0071-0369-32)
0071-0369-40 0071-0369 HUMAN PRESCRIPTION DRUG Dilantin Extended Phenytoin Sodium CAPSULE ORAL 19760827 20251130 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 100 mg/1 100 BLISTER PACK in 1 CARTON (0071-0369-40) / 1 CAPSULE in 1 BLISTER PACK
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