FDA — authorised 26 February 1981
- Application: ANDA086831
- Marketing authorisation holder: MYLAN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 CHLORTHALIDONE in United States
FDA authorised CHLORTHALIDONE on 26 February 1981 · 7,224 US adverse-event reports
Marketing authorisations
FDA — authorised 30 March 2017
- Application: ANDA206904
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 6 August 2019
- Application: ANDA211627
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 11 February 2020
- Application: ANDA213412
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 25 November 2020
- Application: ANDA213302
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 27 November 2020
- Application: ANDA214129
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
FDA — authorised 25 October 2021
- Application: ANDA215560
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 26 August 2022
- Application: ANDA216262
- Marketing authorisation holder: ALEMBIC
- 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: 7,224
Most-reported reactions
- Fatigue — 991 reports (13.72%)
- Drug Ineffective — 934 reports (12.93%)
- Nausea — 867 reports (12%)
- Diarrhoea — 754 reports (10.44%)
- Pain — 659 reports (9.12%)
- Dizziness — 644 reports (8.91%)
- Headache — 621 reports (8.6%)
- Dyspnoea — 606 reports (8.39%)
- Off Label Use — 599 reports (8.29%)
- Arthralgia — 549 reports (7.6%)
CHLORTHALIDONE 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 CHLORTHALIDONE approved in United States?
Yes. FDA authorised it on 26 February 1981; FDA authorised it on 30 March 2017; FDA authorised it on 6 August 2019.
Who is the marketing authorisation holder for CHLORTHALIDONE in United States?
MYLAN holds the US marketing authorisation.