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 |
2019/02/06 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/12/21 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/10/03 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/07/05 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/05/30 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/05/30 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/12 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2017/04/26 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/14 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/09 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/12/18 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/09/14 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/05 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/11/16 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2007/12/20 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/11/19 |
SUPPL-20(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2003/06/25 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/12/10 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/27 |
SUPPL-18(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1999/07/23 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/01/27 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/29 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/05/08 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/01/27 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/01/23 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/07/14 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/09/12 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/10/12 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/09/20 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1995/09/01 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/02/09 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/09/17 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1993/04/12 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |
002 |
4863931 |
2008/09/15 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
4863931*PED |
2009/03/15 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |