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 |
2016/11/08 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/03/30 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/22 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/06/04 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/01/30 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2001/11/26 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/04/25 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/08/17 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/03/23 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/12/16 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/01/29 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/08/07 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/19 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/29 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/02/14 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1989/01/12 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/01/12 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/12/30 |
SUPPL-13(补充) |
Approval |
Bioequivalence |
|
|
|
1988/11/21 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1986/02/12 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/21 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/21 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/21 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/21 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/10/03 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/09/15 |
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 |