FDA — authorised 25 January 1982
- Application: ANDA085755
- Marketing authorisation holder: WATSON LABS
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LIOTHYRONINE SODIUM in United States
FDA authorised LIOTHYRONINE SODIUM on 25 January 1982 · 3,451 US adverse-event reports
Marketing authorisations
FDA — authorised 3 February 1982
- Application: ANDA085753
- Marketing authorisation holder: WATSON LABS
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2005
- Application: ANDA076923
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: LIOTHYRONINE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 March 2009
- Application: ANDA090097
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 2009
- Application: ANDA090326
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2012
- Application: ANDA200295
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211510
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LIOTHYRONINE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA214803
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: LIOTHYRONINE SODIUM
- 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: 3,451
Most-reported reactions
- Headache — 504 reports (14.6%)
- Drug Ineffective — 450 reports (13.04%)
- Hypertension — 355 reports (10.29%)
- Dyspnoea — 328 reports (9.5%)
- Hypothyroidism — 322 reports (9.33%)
- Fatigue — 313 reports (9.07%)
- Asthma — 306 reports (8.87%)
- Gastrooesophageal Reflux Disease — 295 reports (8.55%)
- Therapeutic Product Effect Incomplete — 295 reports (8.55%)
- Burning Sensation — 283 reports (8.2%)
LIOTHYRONINE SODIUM 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 LIOTHYRONINE SODIUM approved in United States?
Yes. FDA authorised it on 25 January 1982; FDA authorised it on 3 February 1982; FDA authorised it on 17 August 2005.
Who is the marketing authorisation holder for LIOTHYRONINE SODIUM in United States?
WATSON LABS holds the US marketing authorisation.