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 |
2014/12/15 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/05/27 |
SUPPL-34(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2005/04/22 |
SUPPL-30(补充) |
Approval |
Supplement |
STANDARD
|
|
|
2004/11/03 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/05/29 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/03/02 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/11/21 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/09/13 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1989/07/13 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1988/10/17 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/06/29 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/01/28 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/11/25 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/24 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/01/10 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/11/14 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/09/05 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/04/20 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/01/30 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1984/01/30 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1984/01/27 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/01/13 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/12/01 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1983/11/22 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1983/08/22 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/08/22 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/04/01 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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 |