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 |
1994/06/28 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1993/10/06 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/07/16 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/04/11 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/11/18 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/11/18 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/11/18 |
SUPPL-30(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/12/19 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/12/19 |
SUPPL-27(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/12/19 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/07/23 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/07/23 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/02/04 |
SUPPL-25(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/10/02 |
SUPPL-21(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/02/22 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/01/23 |
SUPPL-18(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/01/26 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/01 |
SUPPL-16(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1976/06/03 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/04/02 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/07/01 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1970/04/06 |
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 |