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 |
2022/12/06 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/20 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/11/05 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/11 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/10 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/04 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/25 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/16 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/07/17 |
SUPPL-49(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2013/12/23 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/23 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/19 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/08/02 |
SUPPL-44(补充) |
Approval |
REMS |
N/A
|
|
|
2011/07/25 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/05/17 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/05/25 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/02/26 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/01 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/01 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/08/02 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/29 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/07/03 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/07/03 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/02/28 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/01/12 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/05/27 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/22 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/02 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/06/20 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/06/20 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/02/13 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/04/10 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/04/10 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/10/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/11/27 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/11/27 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/03/23 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/03/23 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/03/23 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/06/24 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1991/06/24 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/05/30 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/02/11 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1986/02/11 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1985/12/30 |
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 |