FDA — authorised 12 June 2007
- Application: NDA021853
- Marketing authorisation holder: RELIANT PHARMS
- Local brand name: OMACOR
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 OMACOR in United States
FDA authorised OMACOR on 12 June 2007
Marketing authorisations
FDA
- Status: approved
OMACOR in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is OMACOR approved in United States?
Yes. FDA authorised it on 12 June 2007; FDA has authorised it.
Who is the marketing authorisation holder for OMACOR in United States?
RELIANT PHARMS holds the US marketing authorisation.