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 |
2016/10/25 |
SUPPL-89(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/07/20 |
SUPPL-88(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/05/11 |
SUPPL-87(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/06/19 |
SUPPL-86(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/02/19 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/04/30 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/12/04 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/04/20 |
SUPPL-80(补充) |
Approval |
Labeling |
|
|
|
1991/07/16 |
SUPPL-79(补充) |
Approval |
Labeling |
|
|
|
1990/02/16 |
SUPPL-78(补充) |
Approval |
Labeling |
|
|
|
1988/12/23 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/12/23 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/12/23 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/06/09 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/11/22 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/11/22 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1978/06/23 |
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 |