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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021695 | LUPIN | 2004-11-30 | 6 |
| ANDA 076433 | RHODES PHARMS | 2005-05-13 | 7 |
| NDA 021612 | CIPHER PHARMS INC | 2006-01-11 | 4 |
| ANDA 076509 | IMPAX LABS | 2008-03-26 | 11 |
| ANDA 090856 | LUPIN LTD | 2011-12-23 | 8 |
| ANDA 202856 | MYLAN PHARMS INC | 2012-12-07 | 9 |
| ANDA 202252 | APOTEX | 2013-07-26 | 2 |
| ANDA 201748 | SUN PHARM INDS LTD | 2014-10-31 | 3 |
| ANDA 204019 | LUPIN | 2015-08-17 | 4 |
| ANDA 205118 | AUROBINDO PHARMA | 2016-05-05 | 6 |
| ANDA 204598 | HETERO LABS LTD III | 2016-07-12 | 8 |
| ANDA 200264 | IMPAX LABS INC | 2016-09-07 | 2 |
| ANDA 208709 | CIPLA | 2016-12-15 | 10 |
| ANDA 207378 | INVAGEN PHARMS | 2017-03-28 | 3 |
| ANDA 205566 | GLENMARK PHARMS LTD | 2017-04-07 | 5 |
| ANDA 208705 | ALEMBIC | 2017-05-12 | 4 |
| ANDA 200884 | SUN PHARM | 2017-09-07 | 4 |
| ANDA 207805 | REYOUNG | 2017-11-16 | 3 |
| ANDA 207803 | BOSTAL | 2017-12-19 | 5 |
| ANDA 209951 | AMNEAL | 2018-02-09 | 4 |
| ANDA 209504 | ANI PHARMS | 2018-04-30 | 4 |
| ANDA 210782 | TORRENT | 2018-06-26 | 3 |
| ANDA 210138 | AJANTA PHARMA LTD | 2018-07-20 | 8 |
| ANDA 210606 | RISING | 2018-08-17 | 4 |
| ANDA 211080 | PRINSTON INC | 2018-08-28 | 3 |
| ANDA 210705 | AJANTA PHARMA LTD | 2018-09-10 | 3 |
| ANDA 209660 | CHARTWELL RX | 2019-02-11 | 8 |
| ANDA 210476 | ALEMBIC | 2019-08-09 | 4 |
| ANDA 210670 | DR REDDYS | 2019-09-06 | 3 |
| ANDA 213252 | ALEMBIC | 2020-01-17 | 4 |
| ANDA 211122 | RISING | 2020-03-18 | 6 |
| ANDA 213864 | MANKIND PHARMA | 2020-06-12 | 14 |
| ANDA 213842 | ALEMBIC | 2020-10-19 | 7 |
| ANDA 208476 | BOSTAL | 2021-02-10 | 4 |
| ANDA 212232 | AUROBINDO PHARMA LTD | 2021-09-20 | 3 |
| ANDA 216798 | AUROBINDO PHARMA | 2022-09-27 | 9 |
| ANDA 217732 | CREEKWOOD PHARMS | 2023-09-07 | 8 |
| ANDA 211407 | CHARTWELL | 2024-01-31 | 3 |
| ANDA 210248 | MACLEODS PHARMS | 2024-11-13 | 2 |
| ANDA 210379 | MACLEODS PHARMS | 2026-01-21 | 2 |
Showing 40 of 46 applications.
Official labeling on DailyMed
- FENOFIBRATE TABLET [A-S MEDICATION SOLUTIONS] · version 6 · 2026-09-10
- FENOFIBRATE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- FENOFIBRATE TABLET, COATED [A-S MEDICATION SOLUTIONS] · version 7 · 2026-08-31
- FENOFIBRATE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 4 · 2026-08-28
- FENOFIBRATE (FENOFIBRATE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-08-06
- FENOFIBRATE TABLET [REMEDYREPACK INC.] · version 9 · 2026-08-03
- FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS LLC] · version 5 · 2026-07-31
- FENOFIBRATE TABLET [MAJOR PHARMACEUTICALS] · version 4 · 2026-07-28
- FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] · version 5 · 2026-07-07
- FENOFIBRATE TABLET, FILM COATED [BOSTAL LLC] · version 12 · 2026-07-02
- FENOFIBRATE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 11 · 2026-06-30
- FENOFIBRATE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-06-23
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.