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
Marketing authorisations
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 24 June 1975
- Application: ANDA080575
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1993
- Marketing authorisation holder: HOSPIRA
- Status: approved
FDA — authorised 29 November 2012
- Application: ANDA091623
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Indication: Labeling
- Status: approved
FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 December 2017
- Application: ANDA206106
- Marketing authorisation holder: SAGENT PHARMS INC
- 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
- Status: approved
FDA — authorised 6 November 2024
- Application: ANDA218471
- Marketing authorisation holder: ASPIRO
- Status: approved
FDA — authorised 24 February 2025
- Application: ANDA217800
- Marketing authorisation holder: GLAND
- Local brand name: THIAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083534
- Marketing authorisation holder: WATSON LABS
- 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
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
Thiamine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Thiamine Hydrochloride approved in United States?
Yes. FDA authorised it on 20 June 1972; FDA authorised it on 26 February 1974; FDA authorised it on 26 February 1974.
Who is the marketing authorisation holder for Thiamine Hydrochloride in United States?
FRESENIUS KABI USA holds the US marketing authorisation.