FDA — authorised 16 May 2018
- Application: ANDA091600
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 COLESEVELAM HYDROCHLORIDE in United States
FDA authorised COLESEVELAM HYDROCHLORIDE on 16 May 2018 · 1,201 US adverse-event reports
Marketing authorisations
FDA — authorised 18 May 2018
- Application: ANDA203480
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA202190
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 October 2018
- Application: ANDA209038
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2018
- Application: ANDA210889
- Marketing authorisation holder: DR REDDYS
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 2019
- Application: ANDA210316
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 September 2019
- Application: ANDA208670
- Marketing authorisation holder: BIONPHARMA
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2020
- Application: ANDA212602
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 September 2020
- Application: ANDA202178
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 September 2020
- Application: ANDA200830
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2020
- Application: ANDA212050
- Marketing authorisation holder: INVENTIA
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2020
- Application: ANDA201354
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 October 2021
- Application: ANDA206036
- Marketing authorisation holder: BEIJING TIDE PHARM
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2023
- Application: ANDA212886
- Marketing authorisation holder: IMPAX
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 April 2025
- Application: ANDA204893
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: COLESEVELAM HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,201
Most-reported reactions
- Dyspnoea — 135 reports (11.24%)
- Cough — 133 reports (11.07%)
- Muscle Spasms — 131 reports (10.91%)
- Nasopharyngitis — 122 reports (10.16%)
- Diarrhoea — 121 reports (10.07%)
- Atrial Fibrillation — 115 reports (9.58%)
- Chest Discomfort — 115 reports (9.58%)
- Coronary Artery Disease — 110 reports (9.16%)
- Drug Ineffective — 110 reports (9.16%)
- Dysphonia — 109 reports (9.08%)
COLESEVELAM HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is COLESEVELAM HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 16 May 2018; FDA authorised it on 18 May 2018; FDA authorised it on 16 July 2018.
Who is the marketing authorisation holder for COLESEVELAM HYDROCHLORIDE in United States?
IMPAX LABS INC holds the US marketing authorisation.