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 |
1991/08/26 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/05/09 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/05/05 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/05/05 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/07/06 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/07/06 |
SUPPL-40(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1988/03/31 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/01/22 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/02/25 |
SUPPL-36(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/08/02 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/05/01 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/04/12 |
SUPPL-31(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1983/11/18 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/09/07 |
SUPPL-28(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/12/02 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/10/22 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/06/23 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/04/12 |
SUPPL-6(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/04/12 |
SUPPL-1(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/03/13 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/02/01 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 |