FDA — authorised 21 December 1995
- Application: NDA020421
- Marketing authorisation holder: BAYER
- Local brand name: FEMSTAT 3
- Indication: CREAM — VAGINAL
- Status: approved
🇺🇸 Femstat 3 in United States
FDA authorised Femstat 3 on 21 December 1995
Marketing authorisations
FDA — authorised 18 May 2012
- Application: ANDA200923
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Not Applicable
- Status: approved
Femstat 3 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Femstat 3 approved in United States?
Yes. FDA authorised it on 21 December 1995; FDA authorised it on 18 May 2012.
Who is the marketing authorisation holder for Femstat 3 in United States?
BAYER holds the US marketing authorisation.