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 |
2020/11/03 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/04/27 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/15 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/09/22 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/01/23 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/05 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/05/27 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/03/14 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/07/13 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/01/30 |
SUPPL-29(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
1998/01/30 |
SUPPL-28(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
1997/12/17 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/07/25 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/02/29 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/11/02 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/06/14 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/12/18 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1992/12/02 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1988/07/08 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1981/07/01 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/04 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/05/14 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1975/06/13 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1969/12/11 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1960/06/27 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |