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 |
2017/09/18 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/10/03 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/04/29 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/04/29 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/02/28 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
2010/01/12 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
2009/03/26 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2005/01/06 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
2002/04/11 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
2000/07/07 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/01/10 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/02 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/02 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/12 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/12 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/01/08 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/05/28 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/11/07 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/12/18 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/09/13 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/02/28 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/10/31 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |