FDA — authorised 25 October 1996
- Application: NDA020576
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: CYSTADANE
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Cystadane in United States
FDA authorised Cystadane on 25 October 1996
Marketing authorisations
FDA
- Status: approved
Cystadane 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 Cystadane approved in United States?
Yes. FDA authorised it on 25 October 1996; FDA has authorised it.
Who is the marketing authorisation holder for Cystadane in United States?
RECORDATI RARE holds the US marketing authorisation.