FDA — authorised 2 November 2010
- Application: NDA022450
- Marketing authorisation holder: MALLINCKRODT HOSP
- Local brand name: OFIRMEV
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA authorised Intravenous acetominophen on 2 November 2010
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 2 November 2010; FDA has authorised it.
MALLINCKRODT HOSP holds the US marketing authorisation.