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 |
1998/02/25 |
SUPPL-151(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/07/08 |
SUPPL-150(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/04/24 |
SUPPL-149(补充) |
Approval |
Labeling |
|
|
|
1996/04/24 |
SUPPL-148(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/08/30 |
SUPPL-147(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/04/20 |
SUPPL-145(补充) |
Approval |
Labeling |
|
|
|
1990/01/31 |
SUPPL-144(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/01/12 |
SUPPL-143(补充) |
Approval |
Labeling |
|
|
|
1989/05/18 |
SUPPL-142(补充) |
Approval |
Labeling |
|
|
|
1988/04/26 |
SUPPL-141(补充) |
Approval |
Labeling |
|
|
|
1988/01/15 |
SUPPL-140(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/07/03 |
SUPPL-138(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/11/15 |
SUPPL-136(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/10/22 |
SUPPL-135(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/03/30 |
SUPPL-133(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/17 |
SUPPL-134(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/02 |
SUPPL-132(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/02 |
SUPPL-131(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/01/13 |
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 |