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 |
2021/10/05 |
SUPPL-5401(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/05/14 |
SUPPL-5394(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/05/14 |
SUPPL-5391(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/05/14 |
SUPPL-5389(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/06/19 |
SUPPL-5385(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/10/25 |
SUPPL-5377(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/10/02 |
SUPPL-5373(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/08/27 |
SUPPL-5374(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/01/02 |
SUPPL-5370(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/11/06 |
SUPPL-5359(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/28 |
SUPPL-5345(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/06/28 |
SUPPL-5328(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/10/26 |
SUPPL-5295(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/09/23 |
SUPPL-5301(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2011/09/07 |
SUPPL-5314(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/08/01 |
SUPPL-5317(补充) |
Approval |
Supplement |
|
|
|
2011/02/17 |
SUPPL-5281(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/12/28 |
SUPPL-5259(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/10/04 |
SUPPL-5285(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/07/29 |
SUPPL-5278(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/04/26 |
SUPPL-5260(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/11/18 |
SUPPL-5258(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/05/05 |
SUPPL-5234(补充) |
Approval |
Supplement |
|
|
|
2008/12/22 |
SUPPL-5232(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/08/06 |
SUPPL-5208(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/19 |
SUPPL-5206(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/06/12 |
SUPPL-5189(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/04/19 |
SUPPL-5160(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2006/12/08 |
SUPPL-5163(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/10/13 |
SUPPL-5145(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2006/09/26 |
SUPPL-5129(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2006/08/11 |
SUPPL-5167(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2006/08/11 |
SUPPL-5166(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2006/05/19 |
SUPPL-5138(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2006/03/17 |
SUPPL-5135(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/09/15 |
SUPPL-5113(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2005/05/13 |
SUPPL-5089(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2005/04/05 |
SUPPL-5092(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/12/17 |
SUPPL-5090(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/12/17 |
SUPPL-5077(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2004/10/07 |
SUPPL-5083(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/09/29 |
SUPPL-5073(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2004/07/29 |
SUPPL-5058(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/03/10 |
SUPPL-5069(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/03 |
SUPPL-5056(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/03 |
SUPPL-5020(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/07/14 |
SUPPL-5047(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/07/03 |
SUPPL-5049(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/04/01 |
SUPPL-5032(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2002/06/28 |
SUPPL-5012(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2002/02/27 |
SUPPL-5004(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2001/11/27 |
SUPPL-5006(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/12/29 |
SUPPL-1007(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1999/11/10 |
SUPPL-1004(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1998/08/24 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
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 |