FDA — authorised 1 April 2004
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Ketek in United States
FDA authorised Ketek on 1 April 2004
Marketing authorisations
FDA — authorised 1 April 2004
- Application: NDA021144
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: KETEK
- Indication: TABLET — ORAL
- Status: approved
Ketek 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 Ketek approved in United States?
Yes. FDA authorised it on 1 April 2004; FDA authorised it on 1 April 2004.
Who is the marketing authorisation holder for Ketek in United States?
SANOFI AVENTIS US holds the US marketing authorisation.