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 |
|---|
| 2022/01/05 |
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:ABIRATERONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:250MG 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 |
|---|
| 202379 |
001 |
NDA |
ZYTIGA |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
Yes |
No |
AB |
2011/04/28
|
JANSSEN BIOTECH |
| 208339 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/10/31
|
HIKMA |
| 208432 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/10/31
|
TEVA PHARMS USA |
| 208446 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/10/31
|
MYLAN |
| 208453 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/10/31
|
APOTEX |
| 208327 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/01/07
|
AMNEAL PHARMS |
| 208371 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/02/25
|
RISING |
| 208380 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/02/27
|
WOCKHARDT BIO AG |
| 210686 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/07/10
|
MSN |
| 212462 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/09/27
|
QILU |
| 209227 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/10/16
|
GLENMARK SPECLT |
| 208416 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/05/18
|
DR REDDYS |
| 215947 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2022/01/05
|
NOVUGEN |
活性成分:ABIRATERONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:500MG 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 |
|---|
| 202379 |
002 |
NDA |
ZYTIGA |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
Yes |
Yes |
AB |
2017/04/14
|
JANSSEN BIOTECH |
| 208446 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/12/14
|
MYLAN |
| 208327 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/12/23
|
AMNEAL PHARMS |
| 212462 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2021/06/25
|
QILU |
| 215947 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2022/01/05
|
NOVUGEN |
| 209227 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2022/05/19
|
GLENMARK SPECLT |
| 210726 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/01/26
|
TEVA PHARMS USA |
| 215086 |
001 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/03/23
|
FLORIDA |
| 208416 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/09/01
|
DR REDDYS |
| 210686 |
002 |
ANDA |
ABIRATERONE ACETATE |
ABIRATERONE ACETATE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2024/04/24
|
MSN |