FDA — authorised 25 March 2013
- Application: ANDA200913
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 ABT-335 in United States
FDA authorised ABT-335 on 25 March 2013 · 12 US adverse-event reports
Marketing authorisations
FDA — authorised 18 July 2013
- Application: ANDA201573
- Marketing authorisation holder: PH HEALTH
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 December 2013
- Application: ANDA200750
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 October 2015
- Application: ANDA200920
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 September 2016
- Application: ANDA200264
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 12 May 2017
- Application: ANDA208705
- Marketing authorisation holder: ALEMBIC
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 5 July 2019
- Application: ANDA210469
- Marketing authorisation holder: TWI PHARMS
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 July 2019
- Application: ANDA212598
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2020
- Application: ANDA212562
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 8 February 2024
- Application: ANDA207796
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: FENOFIBRIC ACID
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 12
Most-reported reactions
- Haematuria — 2 reports (16.67%)
- Non-Cardiac Chest Pain — 2 reports (16.67%)
- Abdominal Pain Upper — 1 report (8.33%)
- Aphasia — 1 report (8.33%)
- Back Pain — 1 report (8.33%)
- Diarrhoea — 1 report (8.33%)
- Dysphagia — 1 report (8.33%)
- Dyspnoea — 1 report (8.33%)
- Gastrooesophageal Reflux Disease — 1 report (8.33%)
- Glucose Tolerance Impaired — 1 report (8.33%)
Other Cardiovascular approved in United States
Frequently asked questions
Is ABT-335 approved in United States?
Yes. FDA authorised it on 25 March 2013; FDA authorised it on 18 July 2013; FDA authorised it on 4 December 2013.
Who is the marketing authorisation holder for ABT-335 in United States?
PHARMOBEDIENT holds the US marketing authorisation.