| 产品NDC | 63187-891 |
|---|---|
| 产品类型 | HUMAN PRESCRIPTION DRUG |
| 商品名 | PHENYTOIN SODIUM |
| 通用名 | PHENYTOIN SODIUM |
| 剂型 | CAPSULE, EXTENDED RELEASE |
| 给药途径 | ORAL |
| 市场类别 | ANDA |
| 申请号 | ANDA040621 |
| 标签持有者 | Proficient Rx LP |
| 活性成分 | PHENYTOIN SODIUM |
| 规格 | 100 mg/1 |
| 药学分类 | Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA计划编号 | N/A |
| 上市认证有效期 | 20241231 |
| 产品NDC | NDC包装代码 | 包装描述 | 开始上市日期 | 结束上市日期 | NDC号状态 | 是否样品包装 | 药品说明书 |
|---|---|---|---|---|---|---|---|
| 63187-891 | 63187-891-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-30) | 20170801 | 有效 | 否 | 药品说明书及标签信息 | |
| 63187-891 | 63187-891-60 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-60) | 20170801 | 有效 | 否 | 药品说明书及标签信息 | |
| 63187-891 | 63187-891-90 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-90) | 20170801 | 有效 | 否 | 药品说明书及标签信息 |