FDA — authorised 29 December 1989
- Application: NDA050641
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MONODOX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Monodox in United States
FDA authorised Monodox on 29 December 1989
Marketing authorisations
FDA
- Status: approved
Monodox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Monodox approved in United States?
Yes. FDA authorised it on 29 December 1989; FDA has authorised it.
Who is the marketing authorisation holder for Monodox in United States?
CHARTWELL RX holds the US marketing authorisation.