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 |
1998/10/14 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/08/31 |
SUPPL-78(补充) |
Approval |
Labeling |
|
|
|
1989/01/06 |
SUPPL-77(补充) |
Approval |
Labeling |
|
|
|
1988/01/15 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/01/15 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/09 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/04/29 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/15 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/15 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/15 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/11 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/11 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/11 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/09 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/09 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/10 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/10 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/10 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1972/10/18 |
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 |