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 |
1998/12/01 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/10/16 |
SUPPL-66(补充) |
Approval |
Labeling |
|
|
|
1994/12/23 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/11 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/09/03 |
SUPPL-63(补充) |
Approval |
Labeling |
|
|
|
1992/04/03 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/01/31 |
SUPPL-59(补充) |
Approval |
Labeling |
|
|
|
1991/12/30 |
SUPPL-58(补充) |
Approval |
Labeling |
|
|
|
1990/02/28 |
SUPPL-57(补充) |
Approval |
Labeling |
|
|
|
1990/02/28 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/20 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/02/27 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/02/05 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/07/11 |
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 |