药品注册申请号：208327
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS
申请人全名：AMNEAL PHARMACEUTICALS OF NEW YORK LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ABIRATERONE ACETATE ABIRATERONE ACETATE TABLET;ORAL 250MG No No AB 2019/01/07 2019/01/07 Prescription
002 ABIRATERONE ACETATE ABIRATERONE ACETATE TABLET;ORAL 500MG No No AB 2020/12/23 Prescription
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
2022/09/02 SUPPL-14（补充） Approval Labeling STANDARD
2020/11/20 SUPPL-10（补充） Approval Labeling STANDARD
2019/11/04 SUPPL-3（补充） Approval Labeling STANDARD
2019/01/07 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 PC 2019/04/29**本条是由Drugfuture回溯的历史信息**
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RLDRSTE 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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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