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 |
1994/09/27 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1991/07/25 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1990/11/19 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/29 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/19 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1988/10/14 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1988/07/21 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/07/21 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/07/21 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/06/17 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1984/02/29 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/25 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/12/30 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/12/30 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/12/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/12/30 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/01/07 |
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 |