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 |
1991/04/10 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1986/01/09 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/12 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1984/09/05 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1980/10/22 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1980/08/26 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1976/11/02 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/10/15 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/09/23 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1976/03/25 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1975/08/15 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1975/05/30 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1974/04/18 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1974/04/11 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/04/01 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1974/01/14 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1973/11/27 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1973/11/14 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1971/07/29 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1971/04/14 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1970/08/11 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1969/11/26 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1969/11/26 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1969/11/13 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1969/06/03 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1969/05/27 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1968/12/20 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1968/11/19 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1968/07/12 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1968/04/22 |
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 |