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 |
|---|
| 2022/01/20 |
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
|
|
|
| 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 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 |
Prescription |
Yes |
Yes |
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 |
No |
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 |
