批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2021/02/16 |
SUPPL-62(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/28 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/27 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/27 |
SUPPL-46(补充) |
Approval |
Labeling |
|
|
|
1998/12/11 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1998/08/19 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1998/02/09 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/06/10 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/05/27 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/05/27 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/11/27 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1993/11/18 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/07/31 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/12/28 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1990/05/18 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/07/24 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/10 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1987/10/02 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/10/02 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/10/02 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/18 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/04/18 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/05/01 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/14 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/07/16 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:PHENYTOIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/ML 治疗等效代码:AP
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
084307 |
001 |
ANDA |
PHENYTOIN SODIUM |
PHENYTOIN SODIUM |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
040573 |
001 |
ANDA |
PHENYTOIN SODIUM |
PHENYTOIN SODIUM |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2006/09/13
|
ACELLA |