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 |
2022/11/30 |
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 |
205053 |
001 |
NDA |
NOXAFIL |
POSACONAZOLE |
TABLET, DELAYED RELEASE;ORAL |
100MG |
Discontinued |
Yes |
No |
AB |
2013/11/25
|
MERCK SHARP DOHME |
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 |