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 |
2017/02/27 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2013/01/23 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2011/05/31 |
SUPPL-23(补充) |
Approval |
REMS |
N/A
|
|
|
2010/06/07 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/23 |
SUPPL-21(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2007/02/02 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/26 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/26 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
2002/12/10 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/04/04 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/05/13 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/11/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/10/28 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/11/04 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/07/12 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/02/05 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1957/04/22 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 |