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 |
2021/11/22 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/24 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/29 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
2017/02/10 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/05/23 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/05 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/06 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/02/19 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/11/02 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/06/06 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/01/28 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/08/11 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/03/06 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/10/25 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/03/24 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/01/15 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/16 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/07/22 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/11/13 |
SUPPL-3(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2000/11/11 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/11/22 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/28 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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 |
6268489 |
2018/07/31 |
Y |
|
|
|
|
PDF格式![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |