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 |
2016/04/25 |
SUPPL-309(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/17 |
SUPPL-308(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/06/18 |
SUPPL-307(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/07/11 |
SUPPL-306(补充) |
Approval |
Labeling |
|
|
|
1995/02/16 |
SUPPL-304(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/15 |
SUPPL-305(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/11/30 |
SUPPL-303(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/09/06 |
SUPPL-302(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/06/17 |
SUPPL-301(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/03/23 |
SUPPL-300(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/08/18 |
SUPPL-299(补充) |
Approval |
Labeling |
|
|
|
1992/06/12 |
SUPPL-298(补充) |
Approval |
Labeling |
|
|
|
1992/06/10 |
SUPPL-294(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/12/31 |
SUPPL-295(补充) |
Approval |
Labeling |
|
|
|
1989/04/05 |
SUPPL-293(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/04/05 |
SUPPL-292(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/03/31 |
SUPPL-290(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/11/04 |
SUPPL-287(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/30 |
SUPPL-288(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/30 |
SUPPL-285(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/30 |
SUPPL-280(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/04/28 |
SUPPL-284(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/04/28 |
SUPPL-283(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/12 |
SUPPL-282(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/12 |
SUPPL-281(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/06 |
SUPPL-279(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/06 |
SUPPL-275(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/09/11 |
SUPPL-278(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/12/21 |
SUPPL-276(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/07/27 |
SUPPL-274(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/03/15 |
SUPPL-273(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/12/16 |
SUPPL-271(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/12/12 |
SUPPL-263(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/28 |
SUPPL-270(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/11/19 |
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 |