FDA — authorised 9 June 1961
- Marketing authorisation holder: PARKE DAVIS
- Status: approved
🇺🇸 Nardil in United States
FDA authorised Nardil on 9 June 1961
Marketing authorisations
FDA — authorised 2 August 2007
- Application: NDA011909
- Marketing authorisation holder: PARKE DAVIS
- Indication: Labeling
- Status: approved
FDA — authorised 8 December 2010
- Application: ANDA200181
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
Nardil 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 Nardil approved in United States?
Yes. FDA authorised it on 9 June 1961; FDA authorised it on 2 August 2007; FDA authorised it on 8 December 2010.
Who is the marketing authorisation holder for Nardil in United States?
PARKE DAVIS holds the US marketing authorisation.