FDA — authorised 12 February 2013
- Application: ANDA201511
- Marketing authorisation holder: PH HEALTH
- Local brand name: MAFENIDE ACETATE
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
🇺🇸 Sulfamylon® For 5 % Topical Solution in United States
FDA authorised Sulfamylon® For 5 % Topical Solution on 12 February 2013
Marketing authorisations
FDA — authorised 31 July 2017
- Application: ANDA206716
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: MAFENIDE ACETATE
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
Frequently asked questions
Is Sulfamylon® For 5 % Topical Solution approved in United States?
Yes. FDA authorised it on 12 February 2013; FDA authorised it on 31 July 2017.
Who is the marketing authorisation holder for Sulfamylon® For 5 % Topical Solution in United States?
PH HEALTH holds the US marketing authorisation.