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 |
2002/11/01 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/07/16 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1999/05/27 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1998/12/01 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/08/20 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1997/06/11 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/03/28 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/08/27 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/08/06 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/03/04 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/08/18 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/12/13 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/01/21 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/01/28 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/09/10 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/02/22 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/01/11 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/02/06 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/13 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1987/02/13 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/11/26 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/29 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/13 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/08 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/01/31 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/25 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
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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 |