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 |
2024/11/21 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/28 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/03/22 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2003/05/19 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1988/01/27 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/01/22 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/06/08 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/08/12 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/29 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1983/12/29 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1983/09/19 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/03/06 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/12/15 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/12/15 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/12/15 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/20 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1975/04/22 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1960/05/27 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
STANDARD
|
|
|
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 |