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 |
2007/12/07 |
SUPPL-63(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/07 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/07 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/07 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/07 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/07 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
2007/12/07 |
SUPPL-41(补充) |
Approval |
Labeling |
|
|
|
2007/12/07 |
SUPPL-34(补充) |
Approval |
Labeling |
|
|
|
2007/12/07 |
SUPPL-32(补充) |
Approval |
Efficacy |
|
|
|
2007/12/07 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2007/12/07 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
2007/12/07 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
2001/01/02 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/08/26 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/04/29 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/10/03 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/03/28 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/11/06 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/07/05 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/12/16 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/06/30 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
1992/04/02 |
SUPPL-49(补充) |
Approval |
Labeling |
|
|
|
1991/04/23 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/01/02 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/06/14 |
SUPPL-46(补充) |
Approval |
Labeling |
|
|
|
1989/06/06 |
SUPPL-44(补充) |
Approval |
Labeling |
|
|
|
1988/09/16 |
SUPPL-43(补充) |
Approval |
Labeling |
|
|
|
1988/06/22 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/04/05 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
|
1987/08/17 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1987/07/23 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/02/19 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/03/17 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1986/01/27 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1985/09/23 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1985/08/16 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/05/31 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/03/07 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1983/09/20 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/12/09 |
SUPPL-24(补充) |
Approval |
Efficacy |
|
|
|
1982/05/10 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1982/04/08 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/07/02 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/05/15 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1976/03/12 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1963/07/10 |
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 |