药品注册申请号:211889
申请类型:ANDA (仿制药申请)
申请人:SUN PHARM
申请人全名:SUN PHARMACEUTICAL INDUSTRIES LTD
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 PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG No No AB 2021/04/13 2021/04/13 Prescription
002 PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG No No AB 2021/04/13 Prescription
003 PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG No No AB 2021/04/13 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
2024/05/24 SUPPL-1(补充) Approval Labeling STANDARD
2021/04/13 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
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
与本品治疗等效的药品
活性成分:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:82.5MG 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
209501 001 NDA LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription Yes No AB 2017/10/11 UPJOHN
211593 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription No No AB 2021/04/13 ALVOGEN
211889 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription No No AB 2021/04/13 SUN PHARM
213226 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription No No AB 2021/04/13 MSN
215249 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription No No AB 2022/03/22 RUBICON
215577 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Discontinued No No AB 2022/08/26 ZYDUS PHARMS
215675 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Discontinued No No AB 2022/09/14 SCIEGEN PHARMS INC
214496 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Prescription No No AB 2023/06/01 EPIC PHARMA LLC
活性成分:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:165MG 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
209501 002 NDA LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription Yes No AB 2017/10/11 UPJOHN
211593 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2021/04/13 ALVOGEN
211889 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2021/04/13 SUN PHARM
213226 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2021/04/13 MSN
213313 001 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2021/04/13 APOTEX
215249 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2022/03/22 RUBICON
215577 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Discontinued No No AB 2022/08/26 ZYDUS PHARMS
215675 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Discontinued No No AB 2022/09/14 SCIEGEN PHARMS INC
214496 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Prescription No No AB 2023/06/01 EPIC PHARMA LLC
活性成分:PREGABALIN 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:330MG 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
209501 003 NDA LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription Yes Yes AB 2017/10/11 UPJOHN
211593 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2021/04/13 ALVOGEN
211889 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2021/04/13 SUN PHARM
213226 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2021/04/13 MSN
213313 002 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2021/04/13 APOTEX
215249 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2022/03/22 RUBICON
215577 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Discontinued No No AB 2022/08/26 ZYDUS PHARMS
215675 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Discontinued No No AB 2022/09/14 SCIEGEN PHARMS INC
214496 003 ANDA PREGABALIN PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Prescription No No AB 2023/06/01 EPIC PHARMA LLC
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