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 |
2013/11/08 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/06/25 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2006/07/20 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2000/07/26 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/02/11 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/02/12 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/03/29 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/09/30 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/01/27 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/06/12 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/01/31 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/11/09 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/08/03 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1984/01/09 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/07/05 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/09/27 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1982/09/27 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1982/06/18 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/12/17 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1980/10/14 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/10/06 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/06/06 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/05/29 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/07/27 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/12/08 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/03/01 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/11/14 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1965/12/16 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity and Type 4 - New Combination |
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 |