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 |
1998/12/01 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/10/16 |
SUPPL-94(补充) |
Approval |
Labeling |
|
|
|
1994/12/23 |
SUPPL-93(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/11 |
SUPPL-92(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/09/03 |
SUPPL-91(补充) |
Approval |
Labeling |
|
|
|
1992/04/03 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/01/31 |
SUPPL-87(补充) |
Approval |
Labeling |
|
|
|
1991/12/30 |
SUPPL-86(补充) |
Approval |
Labeling |
|
|
|
1990/02/28 |
SUPPL-85(补充) |
Approval |
Labeling |
|
|
|
1990/02/28 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/02/28 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/02/12 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/09/29 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/31 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/07/11 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/14 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/12 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/12 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/12 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/08/12 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/05/10 |
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 |