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-171(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-169(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/11/02 |
SUPPL-170(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/08/27 |
SUPPL-168(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/11 |
SUPPL-167(补充) |
Approval |
Labeling |
|
|
|
1989/09/27 |
SUPPL-166(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/09/27 |
SUPPL-165(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/03/31 |
SUPPL-164(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/09/19 |
SUPPL-159(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-162(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-161(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/05/28 |
SUPPL-157(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/05 |
SUPPL-154(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/01/29 |
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 |