FDA — authorised 18 July 2000
- Application: NDA020610
- Marketing authorisation holder: VALEANT PHARMS INTL
- Local brand name: COLAZAL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Colazal in United States
FDA authorised Colazal on 18 July 2000
Marketing authorisations
FDA — authorised 28 December 2007
- Application: ANDA077883
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 30 July 2021
- Application: ANDA077806
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 8 June 2023
- Application: ANDA217592
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA — authorised 3 April 2025
- Application: ANDA219422
- Marketing authorisation holder: CARNEGIE
- Status: approved
Colazal in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Colazal approved in United States?
Yes. FDA authorised it on 18 July 2000; FDA authorised it on 28 December 2007; FDA authorised it on 30 July 2021.
Who is the marketing authorisation holder for Colazal in United States?
VALEANT PHARMS INTL holds the US marketing authorisation.