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 |
1997/04/07 |
SUPPL-105(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/01/10 |
SUPPL-104(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/05 |
SUPPL-103(补充) |
Approval |
Labeling |
|
|
|
1990/05/21 |
SUPPL-102(补充) |
Approval |
Labeling |
|
|
|
1989/11/02 |
SUPPL-101(补充) |
Approval |
Labeling |
|
|
|
1989/10/18 |
SUPPL-100(补充) |
Approval |
Labeling |
|
|
|
1987/02/02 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/02 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/10/01 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/07/08 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/03/22 |
SUPPL-93(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/08/22 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/07 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/07/12 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/07/12 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/05/23 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/05 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1972/11/03 |
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 |