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 |
2001/11/02 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/10/12 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
1998/11/23 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/03/09 |
SUPPL-43(补充) |
Approval |
Labeling |
|
|
|
1997/05/09 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/01/18 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/11/25 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
|
1990/11/05 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/05 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/05 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/10/04 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1989/08/04 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1989/08/04 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1985/08/13 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/13 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/13 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/13 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/03/15 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/10/25 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/10/25 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/07/06 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/07/25 |
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 |