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 |
2012/09/14 |
SUPPL-35(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2012/01/19 |
SUPPL-34(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/08/23 |
SUPPL-33(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/01/13 |
SUPPL-31(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2003/10/29 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/12/09 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/10/02 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/09/24 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/04/11 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/03/28 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/07/18 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/02/02 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/10/29 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/02/11 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/09/03 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/04/08 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/11/08 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/09/03 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/09 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/01/17 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/10/18 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/10/18 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/10/18 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/04/19 |
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 |
001 |
4743450 |
2007/02/24 |
|
|
|
|
|
PDF格式![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |
002 |
4743450 |
2007/02/24 |
|
|
|
|
|
PDF格式![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |