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 |
2002/10/21 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/09/17 |
SUPPL-33(补充) |
Approval |
Labeling |
|
|
|
1998/03/05 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1998/01/14 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/09/19 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/06/17 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/06/07 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/10/29 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/12/17 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/29 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1992/03/17 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1992/03/17 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1991/03/15 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1987/05/01 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/06/13 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/08 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/01/10 |
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 |