FDA — authorised 31 December 1993
- Marketing authorisation holder: ABBVIE
- Status: approved
🇺🇸 Tricor (Micronized) in United States
FDA authorised Tricor (Micronized) on 31 December 1993
Marketing authorisations
FDA — authorised 31 December 1993
- Application: NDA019304
- Marketing authorisation holder: ABBVIE
- Local brand name: TRICOR (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 April 2002
- Application: ANDA075753
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 October 2003
- Application: ANDA075868
- Marketing authorisation holder: IMPAX LABS
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 November 2004
- Application: NDA021695
- Marketing authorisation holder: LUPIN
- Local brand name: ANTARA (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 May 2005
- Application: NDA021350
- Marketing authorisation holder: JAGOTEC
- Local brand name: TRIGLIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2005
- Application: ANDA076520
- Marketing authorisation holder: MYLAN
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2008
- Application: ANDA076509
- Marketing authorisation holder: IMPAX LABS
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2011
- Application: ANDA090856
- Marketing authorisation holder: LUPIN LTD
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2012
- Application: ANDA090859
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 December 2012
- Application: ANDA202856
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 2013
- Application: ANDA202579
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 July 2013
- Application: ANDA202252
- Marketing authorisation holder: APOTEX
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 October 2014
- Application: ANDA201748
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 August 2015
- Application: ANDA204019
- Marketing authorisation holder: LUPIN
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2016
- Application: ANDA205118
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA204475
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 2016
- Application: ANDA208709
- Marketing authorisation holder: CIPLA
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2017
- Application: ANDA205566
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 September 2017
- Application: ANDA200884
- Marketing authorisation holder: SUN PHARM
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA207805
- Marketing authorisation holder: REYOUNG
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 December 2017
- Application: ANDA207803
- Marketing authorisation holder: BOSTAL
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2018
- Application: ANDA210782
- Marketing authorisation holder: TORRENT
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA210138
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2018
- Application: ANDA211080
- Marketing authorisation holder: PRINSTON INC
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2018
- Application: ANDA210705
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 February 2019
- Application: ANDA209660
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA207564
- Marketing authorisation holder: NOVAST LABS
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 August 2019
- Application: ANDA210476
- Marketing authorisation holder: ALEMBIC
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA210670
- Marketing authorisation holder: DR REDDYS
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2020
- Application: ANDA213252
- Marketing authorisation holder: ALEMBIC
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2020
- Application: ANDA211122
- Marketing authorisation holder: RISING
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2020
- Application: ANDA213864
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 September 2023
- Application: ANDA217732
- Marketing authorisation holder: CREEKWOOD PHARMS
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2024
- Application: ANDA211407
- Marketing authorisation holder: CHARTWELL
- Local brand name: FENOFIBRATE (MICRONIZED)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 January 2026
- Application: ANDA210379
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: FENOFIBRATE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Tricor (Micronized), a tablet formulation of fenofibrate, for oral administration. This approval was granted to Macleods Pharms Ltd, the marketing authorisation holder, on 21 January 2026. The approval was based on a standard application, with no expedited pathway used.
Tricor (Micronized) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Tricor (Micronized) approved in United States?
Yes. FDA authorised it on 31 December 1993; FDA authorised it on 31 December 1993; FDA authorised it on 9 April 2002.
Who is the marketing authorisation holder for Tricor (Micronized) in United States?
ABBVIE holds the US marketing authorisation.