药品注册申请号：022224
申请类型：NDA (新药申请)
申请人：ABBVIE
申请人全名：ABBVIE INC
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 TRILIPIX CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Yes No AB 2008/12/15 2008/12/15 Prescription
002 TRILIPIX CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Yes Yes AB 2008/12/15 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-17（补充） Approval Labeling 901 REQUIRED
2021/06/03 SUPPL-16（补充） Approval Labeling STANDARD
2019/03/28 SUPPL-15（补充） Approval Labeling STANDARD
2018/11/07 SUPPL-14（补充） Approval Labeling STANDARD
2018/05/18 SUPPL-13（补充） Approval Labeling 901 REQUIRED
2015/11/18 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2015/04/27 SUPPL-11（补充） Approval Labeling STANDARD
2015/04/17 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
2013/01/28 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
2012/09/05 SUPPL-8（补充） Approval Labeling UNKNOWN
2012/09/05 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2011/09/30 SUPPL-6（补充） Approval REMS N/A
2011/09/30 SUPPL-5（补充） Approval Labeling 901 REQUIRED
2011/03/14 SUPPL-4（补充） Approval Labeling UNKNOWN
2010/09/14 SUPPL-3（补充） Approval Labeling UNKNOWN
2008/12/15 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient 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 7259186 2025/01/07 Y PDF格式
002 7259186 2025/01/07 Y PDF格式
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 NE 2011/12/15**本条是由Drugfuture回溯的历史信息**
002 NE 2011/12/15**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:CHOLINE FENOFIBRATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:EQ 45MG FENOFIBRIC ACID 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
022224 001 NDA TRILIPIX CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription Yes No AB 2008/12/15 ABBVIE
201573 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Discontinued No No AB 2013/07/18 ANCHEN PHARMS
200750 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2013/12/04 CHARTWELL RX
200920 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2015/10/07 ACTAVIS ELIZABETH
200264 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2016/09/07 IMPAX LABS INC
208705 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2017/05/12 ALEMBIC
210469 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2019/07/05 TWI PHARMS
211626 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2019/07/18 GRAVITI PHARMS
212598 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2019/07/25 AUROBINDO PHARMA LTD
213450 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2020/06/16 MICRO LABS
212562 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2020/12/23 YICHANG HUMANWELL
207796 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID Prescription No No AB 2024/02/08 MACLEODS PHARMS LTD
活性成分:CHOLINE FENOFIBRATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:EQ 135MG FENOFIBRIC ACID 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
022224 002 NDA TRILIPIX CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription Yes Yes AB 2008/12/15 ABBVIE
201573 001 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Discontinued No No AB 2013/07/18 ANCHEN PHARMS
200750 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2013/12/04 CHARTWELL RX
200920 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2015/10/07 ACTAVIS ELIZABETH
200264 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2016/09/07 IMPAX LABS INC
208705 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2017/05/12 ALEMBIC
210469 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2019/07/05 TWI PHARMS
211626 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2019/07/18 GRAVITI PHARMS
212598 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2019/07/25 AUROBINDO PHARMA LTD
213450 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2020/06/16 MICRO LABS
212562 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2020/12/23 YICHANG HUMANWELL
207796 002 ANDA FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID Prescription No No AB 2024/02/08 MACLEODS PHARMS LTD
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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