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 |
|---|
| 2024/10/25 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2022/01/20 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/01/13 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/06/17 |
SUPPL-11（补充） |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
| 2021/05/31 |
SUPPL-12（补充） |
Approval |
Efficacy |
STANDARD
|
|
|
| 2020/09/16 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/03/11 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/02/21 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/01/04 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/09/09 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| 2015/11/13 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/11/13 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/11 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/11/25 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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:POSACONAZOLE 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB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 |
|---|
| 205053 |
001 |
NDA |
NOXAFIL |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2013/11/25
|
MERCK SHARP DOHME |
