FDA — authorised 15 August 1994
- Application: NDA020392
- Marketing authorisation holder: MYLAN
- Local brand name: CYSTAGON
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Cystagon in United States
FDA authorised Cystagon on 15 August 1994
Marketing authorisations
FDA
- Status: approved
Cystagon 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 Cystagon approved in United States?
Yes. FDA authorised it on 15 August 1994; FDA has authorised it.
Who is the marketing authorisation holder for Cystagon in United States?
MYLAN holds the US marketing authorisation.