FDA — authorised 12 November 1964
- Application: ANDA060570
- Marketing authorisation holder: APOTHECON
- Local brand name: FUNGIZONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA authorised ABLC on 12 November 1964
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 November 1964; FDA authorised it on 1 March 1966; FDA has authorised it.
APOTHECON holds the US marketing authorisation.