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-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/04/05 |
SUPPL-52(补充) |
Approval |
Labeling |
|
|
|
1994/12/23 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/11 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/04/04 |
SUPPL-51(补充) |
Approval |
Labeling |
|
|
|
1992/04/03 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/03/27 |
SUPPL-47(补充) |
Approval |
Labeling |
|
|
|
1987/03/31 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/19 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/19 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/11/19 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/09/30 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/12/07 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/10/21 |
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 |