FDA — authorised 18 October 1996
- Application: NDA020524
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: MENTAX
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Mentax in United States
FDA authorised Mentax on 18 October 1996
Marketing authorisations
FDA — authorised 31 December 1996
- Application: NDA020663
- Marketing authorisation holder: MYLAN BERTEK
- Local brand name: MENTAX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 2 May 2012
- Application: NDA021307
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Indication: Labeling
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA205181
- Marketing authorisation holder: SUN PHARMA CANADA
- Status: approved
Mentax 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 Mentax approved in United States?
Yes. FDA authorised it on 18 October 1996; FDA authorised it on 31 December 1996; FDA authorised it on 2 May 2012.
Who is the marketing authorisation holder for Mentax in United States?
PHARMOBEDIENT holds the US marketing authorisation.