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 |
2014/07/16 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/04/30 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
2007/05/31 |
SUPPL-46(补充) |
Approval |
Labeling |
|
|
|
2001/10/30 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/07/27 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/15 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/07/07 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/08/19 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/08/30 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/05/24 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/03/27 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/07/14 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/12/22 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/02/02 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1993/08/25 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1993/02/26 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1988/11/10 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1968/07/31 |
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 |