FDA — authorised 16 March 1976
- Marketing authorisation holder: XSPIRE
- Status: approved
🇺🇸 Nalfon in United States
FDA authorised Nalfon on 16 March 1976
Marketing authorisations
FDA — authorised 16 March 1976
- Application: NDA017604
- Marketing authorisation holder: PHARMACO
- Local brand name: NALFON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 June 1977
- Application: NDA017710
- Marketing authorisation holder: DISTA
- Local brand name: NALFON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2022
- Application: ANDA214475
- Marketing authorisation holder: RISING
- Status: approved
Nalfon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Nalfon approved in United States?
Yes. FDA authorised it on 16 March 1976; FDA authorised it on 16 March 1976; FDA authorised it on 9 June 1977.
Who is the marketing authorisation holder for Nalfon in United States?
XSPIRE holds the US marketing authorisation.