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 |
1999/02/19 |
SUPPL-627(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-626(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/12/04 |
SUPPL-625(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/11/04 |
SUPPL-624(补充) |
Approval |
Labeling |
|
|
|
1991/11/12 |
SUPPL-623(补充) |
Approval |
Labeling |
|
|
|
1991/11/12 |
SUPPL-622(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/11/12 |
SUPPL-621(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/11/12 |
SUPPL-620(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/11/12 |
SUPPL-619(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/04/15 |
SUPPL-618(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/04/15 |
SUPPL-617(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/04/15 |
SUPPL-616(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/11/03 |
SUPPL-614(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/12/21 |
SUPPL-613(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-611(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-610(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/06 |
SUPPL-608(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/02/01 |
SUPPL-607(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/16 |
SUPPL-605(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/01/27 |
SUPPL-604(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/01/29 |
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 |