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 |
|---|
| 2021/04/28 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/07/22 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/06/07 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/07/08 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2016/05/09 |
SUPPL-9（补充） |
Approval |
Labeling |
901 ORDER
|
|
|
| 2014/03/04 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/10/31 |
SUPPL-6（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2013/08/28 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/08/13 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/01/18 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/04/23 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:FAMOTIDINE; IBUPROFEN 剂型/给药途径:TABLET;ORAL 规格:26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 022519 |
001 |
NDA |
DUEXIS |
FAMOTIDINE; IBUPROFEN |
TABLET;ORAL |
26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2011/04/23
|
HORIZON |
