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 |
2001/12/06 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/12/06 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/25 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/25 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/09/28 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/07/18 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/19 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
1989/02/08 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/02/08 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/12/14 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/17 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/01/18 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/01/18 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/01/18 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/05/14 |
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 |