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 |
2005/04/04 |
SUPPL-198(补充) |
Approval |
Labeling |
|
|
|
2001/02/14 |
SUPPL-196(补充) |
Approval |
Labeling |
|
|
|
2001/01/25 |
SUPPL-195(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/25 |
SUPPL-194(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/05 |
SUPPL-193(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/02/12 |
SUPPL-192(补充) |
Approval |
Labeling |
|
|
|
1994/03/11 |
SUPPL-191(补充) |
Approval |
Labeling |
|
|
|
1994/02/22 |
SUPPL-190(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/03/01 |
SUPPL-188(补充) |
Approval |
Labeling |
|
|
|
1990/01/31 |
SUPPL-185(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/06 |
SUPPL-187(补充) |
Approval |
Labeling |
|
|
|
1989/07/13 |
SUPPL-88(补充) |
Approval |
Bioequivalence |
|
|
|
1987/11/10 |
SUPPL-183(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/09/18 |
SUPPL-179(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/17 |
SUPPL-178(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/26 |
SUPPL-177(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/07/17 |
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 |