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 |
2024/03/15 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/09/23 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2014/06/19 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/05/16 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/11/10 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/04/08 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/08 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/12/05 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/09/28 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2005/03/08 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2004/11/10 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/07/10 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/01/24 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/02/15 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/11/08 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/09 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/10/26 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1993/10/26 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/08/10 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/12/28 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/10/09 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/12 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/05/10 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/06/11 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1984/06/11 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1982/10/08 |
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 |
5980882 |
2017/04/16 |
|
Y |
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |