FDA — authorised 20 December 1995
- Application: NDA050685
- Marketing authorisation holder: BURKE THERAP
- Local brand name: CEDAX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Cedax in United States
FDA authorised Cedax on 20 December 1995
Marketing authorisations
FDA — authorised 20 December 1995
- Application: NDA050686
- Marketing authorisation holder: BURKE THERAP
- Local brand name: CEDAX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Status: approved
Cedax 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 Cedax approved in United States?
Yes. FDA authorised it on 20 December 1995; FDA authorised it on 20 December 1995; FDA has authorised it.
Who is the marketing authorisation holder for Cedax in United States?
BURKE THERAP holds the US marketing authorisation.