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 |
2004/08/24 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/03 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/10/01 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/04/16 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/05/19 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/03/07 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/11/01 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/04/03 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1986/01/17 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1983/12/05 |
SUPPL-22(补充) |
Approval |
Efficacy |
|
|
|
1983/06/06 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1982/12/10 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1982/09/22 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/10/10 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1979/09/07 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/12/14 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/09/14 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/09/14 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/03/10 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1964/06/08 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
PRIORITY
|
|
|
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 |