FDA — authorised 20 June 1972
- Application: ANDA080556
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 THIAMINE HYDROCHLORIDE in United States
FDA authorised THIAMINE HYDROCHLORIDE on 20 June 1972 · 4,472 US adverse-event reports
Marketing authorisations
FDA — authorised 6 December 1972
- Application: ANDA080770
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 February 1974
- Application: ANDA080718
- Marketing authorisation holder: BEL MAR
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1974
- Application: ANDA080712
- Marketing authorisation holder: BEL MAR
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1974
- Application: ANDA080571
- Marketing authorisation holder: DR REDDYS
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 1974
- Application: ANDA080553
- Marketing authorisation holder: WYETH AYERST
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 August 1974
- Application: ANDA083775
- Marketing authorisation holder: DELL LABS
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 June 1975
- Application: ANDA080575
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 1996
- Application: ANDA040079
- Marketing authorisation holder: HOSPIRA
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2012
- Application: ANDA091623
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 2017
- Application: ANDA206106
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 April 2022
- Application: ANDA208703
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 2023
- Application: ANDA215692
- Marketing authorisation holder: CAPLIN
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 2024
- Application: ANDA217181
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 November 2024
- Application: ANDA218471
- Marketing authorisation holder: ASPIRO
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 2025
- Application: ANDA217800
- Marketing authorisation holder: GLAND
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA083534
- Marketing authorisation holder: WATSON LABS
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080667
- Marketing authorisation holder: LUITPOLD
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080509
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087968
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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: 4,472
Most-reported reactions
- Off Label Use — 537 reports (12.01%)
- Nausea — 531 reports (11.87%)
- Pain — 514 reports (11.49%)
- Fatigue — 501 reports (11.2%)
- Drug Ineffective — 448 reports (10.02%)
- Dyspnoea — 445 reports (9.95%)
- Diarrhoea — 428 reports (9.57%)
- Headache — 399 reports (8.92%)
- Condition Aggravated — 351 reports (7.85%)
- Dizziness — 318 reports (7.11%)
THIAMINE 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 THIAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 20 June 1972; FDA authorised it on 6 December 1972; FDA authorised it on 4 February 1974.
Who is the marketing authorisation holder for THIAMINE HYDROCHLORIDE in United States?
FRESENIUS KABI USA holds the US marketing authorisation.