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 |
|---|
| 2024/07/18 |
ORIG-1（原始申请） |
Approval |
|
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 |
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 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 |
|---|
| 212411 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2019/08/21
|
SINOTHERAPEUTICS INC |
| 213454 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
Yes |
AB |
2021/02/01
|
AET PHARMA |
| 214476 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/02/04
|
BIOCON PHARMA |
| 212500 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/04/07
|
DR REDDYS |
| 212226 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/05/10
|
SPECGX LLC |
| 207355 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2022/11/30
|
ACTAVIS LABS FL INC |
| 214321 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/12/08
|
HETERO LABS LTD III |
| 216626 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/12/22
|
AMNEAL |
| 216326 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/06/20
|
WESTMINSTER PHARMS |
| 216488 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/08/28
|
I 3 PHARMS |
| 217119 |
001 |
ANDA |
POSACONAZOLE |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2024/07/18
|
AUROBINDO PHARMA |