FDA — authorised 29 July 2004
- Application: NDA021431
- Marketing authorisation holder: FOREST LABS
- Local brand name: CAMPRAL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Campral in United States
FDA authorised Campral on 29 July 2004
Marketing authorisations
FDA — authorised 16 July 2013
- Application: ANDA202229
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 11 March 2014
- Application: ANDA200142
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 26 May 2017
- Application: ANDA205995
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 18 September 2025
- Application: ANDA219904
- Marketing authorisation holder: BIONPHARMA
- Status: approved
Campral 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 Campral approved in United States?
Yes. FDA authorised it on 29 July 2004; FDA authorised it on 16 July 2013; FDA authorised it on 11 March 2014.
Who is the marketing authorisation holder for Campral in United States?
FOREST LABS holds the US marketing authorisation.