FDA — authorised 26 May 2000
- Marketing authorisation holder: DAIICHI SANKYO
- Status: approved
🇺🇸 Welchol in United States
FDA authorised Welchol on 26 May 2000
Marketing authorisations
FDA — authorised 26 May 2000
- Application: NDA021141
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 May 2000
- Application: NDA021176
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 2013
- Application: NDA022362
- Marketing authorisation holder: COSETTE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 January 2022
- Application: ANDA203480
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2023
- Application: ANDA210889
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 11 October 2024
- Application: ANDA091600
- Marketing authorisation holder: IMPAX LABS INC
- Indication: Labeling
- Status: approved
The FDA approved Welchol, a drug product, for labeling indication on October 11, 2024. The marketing authorization holder is IMPAX LABS INC. The application number for this approval is ANDA091600.
FDA — authorised 18 April 2025
- Application: ANDA204893
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Welchol 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 Welchol approved in United States?
Yes. FDA authorised it on 26 May 2000; FDA authorised it on 26 May 2000; FDA authorised it on 26 May 2000.
Who is the marketing authorisation holder for Welchol in United States?
DAIICHI SANKYO holds the US marketing authorisation.