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 |
2001/01/03 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/04/21 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/10/29 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/03/19 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/27 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/09/18 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1984/01/04 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/10/08 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1979/05/29 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1979/01/04 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1978/05/15 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/05/15 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/07/13 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1977/07/13 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1977/04/27 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/24 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/09/24 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/08/10 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/06/18 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/04/19 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/01/09 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/07/25 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1970/01/15 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
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 |