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 |
2004/09/27 |
SUPPL-218(补充) |
Approval |
Labeling |
|
|
|
2003/06/09 |
SUPPL-215(补充) |
Approval |
Labeling |
|
|
|
2002/11/20 |
SUPPL-210(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/19 |
SUPPL-208(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-207(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/12/04 |
SUPPL-206(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/05/06 |
SUPPL-205(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/01/11 |
SUPPL-204(补充) |
Approval |
Labeling |
|
|
|
1990/04/09 |
SUPPL-203(补充) |
Approval |
Labeling |
|
|
|
1989/10/12 |
SUPPL-202(补充) |
Approval |
Labeling |
|
|
|
1989/10/12 |
SUPPL-201(补充) |
Approval |
Labeling |
|
|
|
1989/04/11 |
SUPPL-200(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/04/11 |
SUPPL-199(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-196(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/03 |
SUPPL-195(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/06/16 |
SUPPL-191(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/11/03 |
SUPPL-187(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/23 |
SUPPL-184(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/23 |
SUPPL-155(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/01/29 |
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 |