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 |
2018/05/21 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/04/19 |
SUPPL-24(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/07/17 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/07/17 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/13 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/12/28 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/10 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/05 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/05/21 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/03/07 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/04/16 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/10/03 |
SUPPL-3(补充) |
Approval |
Efficacy |
|
|
|
1991/09/25 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/10/29 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/05/06 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
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 |
001 |
4808610 |
2006/10/02 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
4808610*PED |
2007/04/02 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |