药品注册申请号：205566
申请类型：ANDA (仿制药申请)
申请人：GLENMARK PHARMS LTD
申请人全名：GLENMARK PHARMACEUTICALS 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 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG No No AB 2017/04/07 2017/04/07 Prescription
002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG No No AB 2017/04/07 Prescription
003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG No No AB 2017/04/07 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
2021/06/03 SUPPL-5（补充） Approval Labeling STANDARD
2019/05/15 SUPPL-3（补充） Approval Labeling STANDARD
2018/05/18 SUPPL-2（补充） Approval Labeling STANDARD
2017/04/07 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
无
与本品治疗等效的药品
活性成分:FENOFIBRATE 剂型/给药途径:CAPSULE;ORAL 规格:67MG 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
075753 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2002/09/03 RHODES PHARMS
075868 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Discontinued No No AB 2003/10/27 IMPAX LABS
207378 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Discontinued No No AB 2017/03/28 INVAGEN PHARMS
205566 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2017/04/07 GLENMARK PHARMS LTD
207805 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2017/11/16 REYOUNG
209504 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2018/04/30 ANI PHARMS
210782 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2018/06/26 TORRENT
210705 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2018/09/10 AJANTA PHARMA LTD
213842 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2020/10/19 ALEMBIC
212232 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2021/09/20 AUROBINDO PHARMA LTD
211407 001 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG Prescription No No AB 2024/01/31 CHARTWELL
活性成分:FENOFIBRATE 剂型/给药途径:CAPSULE;ORAL 规格:134MG 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
075753 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2002/04/09 RHODES PHARMS
075868 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Discontinued No No AB 2003/10/27 IMPAX LABS
207378 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Discontinued No No AB 2017/03/28 INVAGEN PHARMS
205566 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2017/04/07 GLENMARK PHARMS LTD
207805 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2017/11/16 REYOUNG
209504 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2018/04/30 ANI PHARMS
210782 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2018/06/26 TORRENT
210705 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2018/09/10 AJANTA PHARMA LTD
213842 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2020/10/19 ALEMBIC
212232 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2021/09/20 AUROBINDO PHARMA LTD
211407 002 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG Prescription No No AB 2024/01/31 CHARTWELL
活性成分:FENOFIBRATE 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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
075753 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2002/04/09 RHODES PHARMS
075868 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Discontinued No No AB 2003/10/27 IMPAX LABS
207378 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Discontinued No No AB 2017/03/28 INVAGEN PHARMS
205566 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2017/04/07 GLENMARK PHARMS LTD
207805 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2017/11/16 REYOUNG
209504 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2018/04/30 ANI PHARMS
210782 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2018/06/26 TORRENT
210705 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No Yes AB 2018/09/10 AJANTA PHARMA LTD
213842 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2020/10/19 ALEMBIC
212232 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2021/09/20 AUROBINDO PHARMA LTD
211407 003 ANDA FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG Prescription No No AB 2024/01/31 CHARTWELL
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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