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 |
2016/12/13 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/30 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/05/18 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/03/17 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/02/26 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/01/13 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/06/23 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/26 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/18 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/15 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/17 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/07/18 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/04/10 |
SUPPL-45(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2008/01/03 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/01/03 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/01/03 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2007/02/15 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/11/18 |
SUPPL-27(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2005/06/28 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/06/28 |
SUPPL-21(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2002/04/22 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/09/17 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/09/17 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/05/02 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/04/13 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1999/12/01 |
SUPPL-9(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1999/11/24 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/11/03 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/10/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/26 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/09/25 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/09/25 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/07/09 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/12/17 |
SUPPL-4(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
1997/09/12 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/03/24 |
SUPPL-2(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1996/08/07 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
;Orphan
|
|
|
1995/12/29 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
;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 |
001 |
5763394 |
2015/06/09 |
|
Y |
|
|
|
PDF格式![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |
002 |
5763394 |
2015/06/09 |
|
Y |
|
|
|
PDF格式![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |