FDA — authorised 18 May 2012
- Application: ANDA200923
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: GYNAZOLE-1
- Indication: CREAM — VAGINAL
- Status: approved
FDA authorised Gynazole 1 vaginal cream on 18 May 2012
Yes. FDA authorised it on 18 May 2012.
PADAGIS ISRAEL holds the US marketing authorisation.