FDA — authorised 10 May 2016
- Application: NDA208081
- Marketing authorisation holder: BIOFRONTERA
- Local brand name: AMELUZ
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 BF-200 ALA 10% in United States
FDA authorised BF-200 ALA 10% on 10 May 2016
Marketing authorisation
Frequently asked questions
Is BF-200 ALA 10% approved in United States?
Yes. FDA authorised it on 10 May 2016.
Who is the marketing authorisation holder for BF-200 ALA 10% in United States?
BIOFRONTERA holds the US marketing authorisation.