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 |
1997/11/26 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/07/16 |
SUPPL-35(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1994/07/08 |
SUPPL-34(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1989/12/07 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/03/17 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/03/17 |
SUPPL-29(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1989/03/17 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/10/09 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/24 |
SUPPL-27(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1986/06/04 |
SUPPL-25(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/11/29 |
SUPPL-23(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/05/17 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/08/21 |
SUPPL-21(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/08/16 |
SUPPL-20(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/08/16 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/04/01 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/04/01 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/06/24 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/01/04 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/08/01 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/10/20 |
SUPPL-12(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/10/13 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/05/25 |
SUPPL-11(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1976/12/22 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/12/22 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/10/07 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1974/12/18 |
SUPPL-6(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1974/12/18 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1973/07/31 |
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 |