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 |
2003/01/03 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/02/08 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/08/02 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/08/02 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/02/05 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/12/23 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/08/29 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/09/04 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/02/06 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/11/09 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/11/16 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/04/13 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/04/07 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/12/30 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/12/30 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/12/30 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/12/22 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/05/28 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/01/14 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/01/02 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/01/02 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/02/26 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/08/30 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/09 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
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 |