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 |
2015/12/23 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/02/04 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/01/19 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/03/06 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/01/26 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/19 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/17 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/10/20 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1986/07/08 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/30 |
SUPPL-22(补充) |
Approval |
Efficacy |
|
|
|
1986/01/30 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1984/09/18 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/02/18 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/01/04 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1982/08/30 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/05/07 |
SUPPL-13(补充) |
Approval |
Efficacy |
|
|
|
1981/10/30 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1980/07/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/03 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/11 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/01 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/12/20 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1979/01/05 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/10/18 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1950/08/15 |
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 |