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 |
1999/02/19 |
SUPPL-119(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-117(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/11/18 |
SUPPL-114(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/04/06 |
SUPPL-116(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/04/06 |
SUPPL-115(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/04/10 |
SUPPL-113(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/06/05 |
SUPPL-111(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/09/01 |
SUPPL-107(补充) |
Approval |
Labeling |
|
|
|
1994/09/01 |
SUPPL-106(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/03/15 |
SUPPL-105(补充) |
Approval |
Labeling |
|
|
|
1992/12/01 |
SUPPL-104(补充) |
Approval |
Labeling |
|
|
|
1991/10/28 |
SUPPL-103(补充) |
Approval |
Labeling |
|
|
|
1991/06/07 |
SUPPL-102(补充) |
Approval |
Labeling |
|
|
|
1989/11/21 |
SUPPL-101(补充) |
Approval |
Labeling |
|
|
|
1989/02/27 |
SUPPL-99(补充) |
Approval |
Labeling |
|
|
|
1989/02/09 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/02/09 |
SUPPL-97(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/01/19 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/06/11 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/10 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/03/14 |
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 |