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Active ingredient

Fenofibrate

221 finished FDA listings contain Fenofibrate as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
FENOFIBRATE, FENOFIBRIC ACID
Dosage forms
Capsule, Capsule, Delayed Release, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
54
Strengths listed
120 mg/1 · 130 mg/1 · 134 mg/1 · 135 mg/1 · 145 mg/1 · 150 mg/1 · 160 mg/1 · 200 mg/1 · 30 mg/1 · 40 mg/1 · 43 mg/1 · 45 mg/1 · 48 mg/1 · 50 mg/1 · 54 mg/1 · 67 mg/1 · 90 mg/1
Brand names in FDA listings
Antara, Lipofen, Tricor

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8703

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021695LUPIN2004-11-306
ANDA 076433RHODES PHARMS2005-05-137
NDA 021612CIPHER PHARMS INC2006-01-114
ANDA 076509IMPAX LABS2008-03-2611
ANDA 090856LUPIN LTD2011-12-238
ANDA 202856MYLAN PHARMS INC2012-12-079
ANDA 202252APOTEX2013-07-262
ANDA 201748SUN PHARM INDS LTD2014-10-313
ANDA 204019LUPIN2015-08-174
ANDA 205118AUROBINDO PHARMA2016-05-056
ANDA 204598HETERO LABS LTD III2016-07-128
ANDA 200264IMPAX LABS INC2016-09-072
ANDA 208709CIPLA2016-12-1510
ANDA 207378INVAGEN PHARMS2017-03-283
ANDA 205566GLENMARK PHARMS LTD2017-04-075
ANDA 208705ALEMBIC2017-05-124
ANDA 200884SUN PHARM2017-09-074
ANDA 207805REYOUNG2017-11-163
ANDA 207803BOSTAL2017-12-195
ANDA 209951AMNEAL2018-02-094
ANDA 209504ANI PHARMS2018-04-304
ANDA 210782TORRENT2018-06-263
ANDA 210138AJANTA PHARMA LTD2018-07-208
ANDA 210606RISING2018-08-174
ANDA 211080PRINSTON INC2018-08-283
ANDA 210705AJANTA PHARMA LTD2018-09-103
ANDA 209660CHARTWELL RX2019-02-118
ANDA 210476ALEMBIC2019-08-094
ANDA 210670DR REDDYS2019-09-063
ANDA 213252ALEMBIC2020-01-174
ANDA 211122RISING2020-03-186
ANDA 213864MANKIND PHARMA2020-06-1214
ANDA 213842ALEMBIC2020-10-197
ANDA 208476BOSTAL2021-02-104
ANDA 212232AUROBINDO PHARMA LTD2021-09-203
ANDA 216798AUROBINDO PHARMA2022-09-279
ANDA 217732CREEKWOOD PHARMS2023-09-078
ANDA 211407CHARTWELL2024-01-313
ANDA 210248MACLEODS PHARMS2024-11-132
ANDA 210379MACLEODS PHARMS2026-01-212

Showing 40 of 46 applications.

Official labeling on DailyMed

Showing the 12 most recent of 141 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.