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-195(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-194(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/06/08 |
SUPPL-193(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/01/24 |
SUPPL-192(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/04/15 |
SUPPL-190(补充) |
Approval |
Labeling |
|
|
|
1991/01/11 |
SUPPL-188(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/11 |
SUPPL-187(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/11/08 |
SUPPL-189(补充) |
Approval |
Labeling |
|
|
|
1988/12/30 |
SUPPL-182(补充) |
Approval |
Bioequivalence |
|
|
|
1986/06/16 |
SUPPL-181(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/10/31 |
SUPPL-180(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/09/17 |
SUPPL-179(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/19 |
SUPPL-178(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/05 |
SUPPL-177(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/02/13 |
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 |