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 |
2008/04/17 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/07/27 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/07/27 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/04/02 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/05/22 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/05/22 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/05/22 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
2002/12/02 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/10/10 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/02/26 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/02/01 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/20 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/11/22 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/03/11 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/07/13 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/09/20 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/10/04 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/03/30 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/05/13 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1988/05/03 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/12/22 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1987/10/06 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/09/25 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1987/07/22 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/05/27 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/04/08 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1986/08/15 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1985/09/30 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/06/19 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1985/06/03 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/05/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/01/30 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/08/23 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1984/08/06 |
SUPPL-8(补充) |
Approval |
Efficacy |
|
|
|
1984/08/06 |
SUPPL-1(补充) |
Approval |
Efficacy |
|
|
|
1984/08/01 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/07/05 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/03/18 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/03/01 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/12/29 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |