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 |
2020/07/22 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2020/01/28 |
SUPPL-73(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/08/10 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/03/10 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/02/27 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/08/13 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/07/10 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/01/29 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2009/11/05 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/08/21 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/10/28 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/08/07 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/04/10 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/05/16 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/10/04 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/02/04 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/02/03 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/03/17 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/03/21 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/03/06 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/02/09 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1993/09/03 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1993/04/26 |
SUPPL-38(补充) |
Approval |
Efficacy |
|
|
|
1992/10/08 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/06/03 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1991/02/15 |
SUPPL-35(补充) |
Approval |
Efficacy |
|
|
|
1990/03/09 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/08/26 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/22 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/22 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/07/05 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/06/27 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/06/12 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/05/29 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/06/02 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/09/17 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1982/09/17 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1982/09/15 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1982/05/13 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/04/19 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/04/03 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/09/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/06/29 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/06/14 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/06/14 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/03/23 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/09/12 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1978/04/25 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/12/22 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/02 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/02 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/07/28 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/04/21 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1974/01/30 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |