FDA — authorised 22 April 1957
- Marketing authorisation holder: RECORDATI RARE
- Status: approved
🇺🇸 Peganone in United States
FDA authorised Peganone on 22 April 1957
Marketing authorisations
FDA — authorised 22 April 1957
- Application: NDA010841
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: PEGANONE
- Indication: TABLET — ORAL
- Status: approved
Peganone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Peganone approved in United States?
Yes. FDA authorised it on 22 April 1957; FDA authorised it on 22 April 1957.
Who is the marketing authorisation holder for Peganone in United States?
RECORDATI RARE holds the US marketing authorisation.