FDA — authorised 4 April 1977
- Application: NDA017563
- Marketing authorisation holder: PFIZER
- Local brand name: COLESTID
- Indication: GRANULE — ORAL
- Status: approved
🇺🇸 Colestid in United States
FDA authorised Colestid on 4 April 1977
Marketing authorisations
FDA — authorised 4 April 1977
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
FDA — authorised 19 July 1994
- Application: NDA020222
- Marketing authorisation holder: PFIZER
- Local brand name: COLESTID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2006
- Application: ANDA077277
- Marketing authorisation holder: IMPAX LABS
- Status: approved
FDA — authorised 9 October 2014
- Application: ANDA077510
- Marketing authorisation holder: IMPAX LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 March 2022
- Application: ANDA215223
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 16 August 2024
- Application: ANDA217667
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Status: approved
Colestid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Colestid approved in United States?
Yes. FDA authorised it on 4 April 1977; FDA authorised it on 4 April 1977; FDA authorised it on 19 July 1994.
Who is the marketing authorisation holder for Colestid in United States?
PFIZER holds the US marketing authorisation.