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 |
1993/04/08 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
1992/11/16 |
SUPPL-44(补充) |
Approval |
Labeling |
|
|
|
1991/07/09 |
SUPPL-42(补充) |
Approval |
Labeling |
|
|
|
1991/04/15 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/16 |
SUPPL-41(补充) |
Approval |
Labeling |
|
|
|
1990/01/03 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/12 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1989/11/21 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1989/02/16 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1988/11/01 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/04/14 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1986/10/07 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/03 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/14 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/14 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/11/20 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/06/12 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/07/07 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/06/09 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/05/12 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/30 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/04/10 |
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 |