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 |
2014/10/23 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/09/14 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/16 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/09/28 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/02/17 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/05/27 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/05/27 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/05/31 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/01/30 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/01/30 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/01/30 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/03/29 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/05/12 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1991/08/28 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1987/10/06 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1986/01/10 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1978/04/12 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1975/03/21 |
SUPPL-16(补充) |
Approval |
Efficacy |
|
|
|
1974/11/04 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1973/10/04 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1972/10/26 |
ORIG-1(原始申请) |
Approval |
|
UNKNOWN
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)