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 |
1994/06/28 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/03/25 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/03/25 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/04/13 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/04/11 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/12/19 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1984/11/15 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/01/21 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/23 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/02/04 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1980/10/02 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1980/03/28 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/13 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1978/01/30 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/03/19 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1972/04/24 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
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 |