药品注册申请号:209501
申请类型:NDA (新药申请)
申请人:UPJOHN
申请人全名:UPJOHN US 2 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 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Yes No AB 2017/10/11 2017/10/11 Prescription
002 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Yes No AB 2017/10/11 Prescription
003 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Yes Yes AB 2017/10/11 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
2023/12/13 SUPPL-5(补充) Approval Labeling STANDARD
2020/04/03 SUPPL-3(补充) Approval Labeling STANDARD
2017/10/11 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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
001 10022447 2026/11/02 U-2136 U-2137 2018/08/16 PDF格式
10022447*PED 2027/05/02 PDF格式
8945620 2026/11/02 Y U-2137 U-2136 2017/11/09 PDF格式
8945620*PED 2027/05/02 PDF格式
9144559 2026/11/02 Y 2017/11/09 PDF格式
9144559*PED 2027/05/02 PDF格式
002 10022447 2026/11/02 U-2137 U-2136 2018/08/16 PDF格式
10022447*PED 2027/05/02 PDF格式
8945620 2026/11/02 Y U-2137 U-2136 2017/11/09 PDF格式
8945620*PED 2027/05/02 PDF格式
9144559 2026/11/02 Y 2017/11/09 PDF格式
9144559*PED 2027/05/02 PDF格式
003 10022447 2026/11/02 U-2136 U-2137 2018/08/16 PDF格式
10022447*PED 2027/05/02 PDF格式
8945620 2026/11/02 Y U-2137 U-2136 2017/11/09 PDF格式
8945620*PED 2027/05/02 PDF格式
9144559 2026/11/02 Y 2017/11/09 PDF格式
9144559*PED 2027/05/02 PDF格式
001 6197819 2018/12/30 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6197819*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
8945620 2026/11/02 Y U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920 2018/12/30 U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6197819 2018/12/30 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6197819*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
8945620 2026/11/02 Y U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920 2018/12/30 U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6197819 2018/12/30 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6197819*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
8945620 2026/11/02 Y U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920 2018/12/30 U-2136 U-2137 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41920*PED 2019/06/30 PDF格式**本条是由Drugfuture回溯的历史信息**
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 NP 2020/10/11**本条是由Drugfuture回溯的历史信息**
PED 2021/04/11**本条是由Drugfuture回溯的历史信息**
002 NP 2020/10/11**本条是由Drugfuture回溯的历史信息**
PED 2021/04/11**本条是由Drugfuture回溯的历史信息**
003 NP 2020/10/11**本条是由Drugfuture回溯的历史信息**
PED 2021/04/11**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: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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