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 |
2000/08/10 |
SUPPL-210(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/25 |
SUPPL-212(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/05 |
SUPPL-211(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/03/07 |
SUPPL-209(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/01/13 |
SUPPL-208(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/10/31 |
SUPPL-206(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/10/31 |
SUPPL-205(补充) |
Approval |
Labeling |
|
|
|
1991/10/31 |
SUPPL-204(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/01/31 |
SUPPL-203(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/09/25 |
SUPPL-200(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/06/28 |
SUPPL-199(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/25 |
SUPPL-198(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/08 |
SUPPL-152(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/10/25 |
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 |