| Active ingredient (INN) | Omega-3-Acid |
|---|---|
| Brand names | Omega-3-Acid, Ethyl Esters, Capsules, USP |
| Therapeutic category | Auto-created by FDA MedWatch — Drug Safety Alerts scraper |
| Controlled substance | No |
|---|
| Marketing-authorisation holders | Mylan Health Pty Ltd, Par Pharmaceutical Inc., NCS HealthCare of KY, LLC dba Vangard Labs, Bryant Ranch Prepack |
|---|
| Registrations on file | 4 |
|---|
| Patient information leaflet (PIL) | Not on file |
|---|
| Summary of product characteristics (SPC) | Not on file |
|---|
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Omacor | 1000 mg | — | 🇦🇺 AU | Mylan Health Pty Ltd | Active |
| Omega-3-acid ethyl esters | 900mg/1 | capsule | 🇺🇸 US | Par Pharmaceutical Inc. | Active |
| Omega-3-Acid Ethyl Esters | 1g/1 | capsule | 🇺🇸 US | NCS HealthCare of KY, LLC dba Vangard Labs | Active |
| Omega-3-Acid Ethyl Ester | 900mg/1 | capsule | 🇺🇸 US | Bryant Ranch Prepack | Active |