FDA — authorised 16 March 1999
- Application: NDA020576
- Marketing authorisation holder: RECORDATI RARE
- Indication: Labeling
- Status: approved
🇺🇸 Cystadane in United States
FDA authorised Cystadane on 16 March 1999
Marketing authorisations
FDA — authorised 23 November 2021
- Application: ANDA214864
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: BETAINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 28 January 2022
- Application: ANDA210508
- Marketing authorisation holder: ETON
- Local brand name: BETAINE
- Indication: FOR SOLUTION — ORAL
- 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 16 March 1999; FDA authorised it on 23 November 2021; FDA authorised it on 28 January 2022.
Who is the marketing authorisation holder for Cystadane in United States?
RECORDATI RARE holds the US marketing authorisation.