FDA — authorised 12 June 2007
- Application: NDA021738
- Marketing authorisation holder: RISING
- Local brand name: EXTINA
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
🇺🇸 ketoconazole 2% foam in United States
FDA authorised ketoconazole 2% foam on 12 June 2007
Marketing authorisations
FDA
- Status: approved
ketoconazole 2% foam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ketoconazole 2% foam approved in United States?
Yes. FDA authorised it on 12 June 2007; FDA has authorised it.
Who is the marketing authorisation holder for ketoconazole 2% foam in United States?
RISING holds the US marketing authorisation.