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 |
2002/07/08 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/06/06 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/02/12 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/07/18 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/04 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/04 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/09/15 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/08/18 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/06/29 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/05/25 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/11/22 |
SUPPL-80(补充) |
Approval |
Labeling |
|
|
|
1999/11/22 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/03/04 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/19 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/02 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/29 |
SUPPL-74(补充) |
Approval |
Labeling |
|
|
|
1997/10/29 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/12/04 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/02/11 |
SUPPL-71(补充) |
Approval |
Labeling |
|
|
|
1989/05/09 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/05/09 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/07 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1978/08/16 |
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 |