FDA — authorised 15 December 1986
- Application: NDA019500
- Marketing authorisation holder: NOVARTIS
- Local brand name: LAMPRENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Clofazimine Oral Product on 15 December 1986
Yes. FDA authorised it on 15 December 1986.
NOVARTIS holds the US marketing authorisation.