FDA — authorised 6 November 1991
- Application: NDA019678
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ENLON-PLUS
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Enlon-Plus on 6 November 1991
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 November 1991; FDA authorised it on 6 November 1991; FDA has authorised it.
PHARMOBEDIENT holds the US marketing authorisation.