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 |
2017/04/03 |
SUPPL-86(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/15 |
SUPPL-88(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-85(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/10 |
SUPPL-84(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/11 |
SUPPL-83(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/06/09 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/11/20 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/04/03 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/11/28 |
SUPPL-67(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/11/28 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/09/07 |
SUPPL-57(补充) |
Approval |
Labeling |
|
|
|
1995/04/18 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/04/12 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/07/27 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/06/16 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/02/18 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/02/17 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/06/23 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/02/20 |
SUPPL-56(补充) |
Approval |
Labeling |
|
|
|
1980/05/20 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/13 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
1979/01/19 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/12/04 |
SUPPL-42(补充) |
Approval |
Labeling |
|
|
|
1976/11/01 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/01 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/01 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1976/01/16 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1960/09/23 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |