FDA — authorised 30 August 2002
- Application: ANDA075478
- Marketing authorisation holder: BARR
- Status: supplemented
🇺🇸 "Conventional" regimen in United States
FDA authorised "Conventional" regimen on 30 August 2002
Marketing authorisations
FDA — authorised 24 February 2004
- Application: ANDA076455
- Marketing authorisation holder: DURAMED PHARMS BARR
- Status: approved
Other Psychiatry approved in United States
Frequently asked questions
Is "Conventional" regimen approved in United States?
Yes. FDA authorised it on 30 August 2002; FDA authorised it on 24 February 2004.
Who is the marketing authorisation holder for "Conventional" regimen in United States?
BARR holds the US marketing authorisation.