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 |
1997/07/08 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/05/05 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/09/29 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/09/28 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1994/02/03 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1993/01/29 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/01/27 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/06/25 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1991/03/28 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/04/19 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1989/05/10 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/02/10 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/11/23 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/08 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/25 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/25 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/16 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/16 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/16 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/06/22 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/06/22 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/05/15 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |