FDA — authorised 7 April 2014
- Application: ANDA091028
- Marketing authorisation holder: GLW
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 OMEGA-3-ACID ETHYL ESTERS in United States
FDA authorised OMEGA-3-ACID ETHYL ESTERS on 7 April 2014 · 921 US adverse-event reports
Marketing authorisations
FDA — authorised 24 June 2014
- Application: ANDA091018
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 2014
- Application: ANDA090973
- Marketing authorisation holder: APOTEX
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 November 2015
- Application: ANDA204940
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA203893
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Status: supplemented
FDA — authorised 25 February 2019
- Application: ANDA207420
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 June 2019
- Application: ANDA210107
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA211355
- Marketing authorisation holder: SOFGEN PHARMS
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 August 2019
- Application: ANDA206455
- Marketing authorisation holder: CHARTWELL
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 January 2020
- Application: ANDA210834
- Marketing authorisation holder: SUN PHARM
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 May 2020
- Application: ANDA211979
- Marketing authorisation holder: CSPC-NBP PHARM
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 2020
- Application: ANDA210093
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 August 2020
- Application: ANDA212504
- Marketing authorisation holder: GLW
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 November 2021
- Application: ANDA215458
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 December 2023
- Application: ANDA211345
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 921
Most-reported reactions
- Product Odour Abnormal — 174 reports (18.89%)
- Diarrhoea — 104 reports (11.29%)
- Nausea — 96 reports (10.42%)
- Chest Pain — 92 reports (9.99%)
- Drug Ineffective — 91 reports (9.88%)
- Pain — 78 reports (8.47%)
- Off Label Use — 77 reports (8.36%)
- Malaise — 75 reports (8.14%)
- Dyspnoea — 67 reports (7.27%)
- Fatigue — 67 reports (7.27%)
OMEGA-3-ACID ETHYL ESTERS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is OMEGA-3-ACID ETHYL ESTERS approved in United States?
Yes. FDA authorised it on 7 April 2014; FDA authorised it on 24 June 2014; FDA authorised it on 30 September 2014.
Who is the marketing authorisation holder for OMEGA-3-ACID ETHYL ESTERS in United States?
GLW holds the US marketing authorisation.