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 |
1997/05/05 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/21 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/22 |
SUPPL-87(补充) |
Approval |
Labeling |
|
|
|
1989/10/18 |
SUPPL-86(补充) |
Approval |
Labeling |
|
|
|
1989/08/04 |
SUPPL-85(补充) |
Approval |
Labeling |
|
|
|
1988/03/28 |
SUPPL-84(补充) |
Approval |
Labeling |
|
|
|
1983/11/30 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/04 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/04 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/10/18 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/10/18 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/10/18 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/24 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/18 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1972/07/12 |
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 |