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 |
2020/08/24 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/24 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/14 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2012/12/21 |
SUPPL-25(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/11/20 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/07/24 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/08 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/09/05 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/12 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/04/29 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/01/15 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/07/30 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/05/10 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/04/15 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/04/15 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/10/22 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/10/20 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/02/28 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/01/19 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/06/14 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1988/02/04 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/05/13 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/11/20 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/03/30 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
PRIORITY
|
|
|
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 |