FDA — authorised 14 August 1972
- Application: ANDA080618
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: PYRIDOXINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Pyridoxine Hydrochloride in United States
FDA authorised Pyridoxine Hydrochloride on 14 August 1972
Marketing authorisations
FDA — authorised 13 February 1974
- Application: ANDA080572
- Marketing authorisation holder: DR REDDYS
- Local brand name: PYRIDOXINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 March 1983
- Application: ANDA080581
- Marketing authorisation holder: ELKINS SINN
- Local brand name: PYRIDOXINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1993
- Marketing authorisation holder: HOSPIRA
- Status: approved
FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA208518
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 18 June 2018
- Application: NDA209661
- Marketing authorisation holder: DUCHESNAY
- Indication: Labeling
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA205811
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA207825
- Marketing authorisation holder: PHARMOBEDIENT
- Status: approved
FDA
- Application: ANDA087967
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PYRIDOXINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080669
- Marketing authorisation holder: LUITPOLD
- Local brand name: PYRIDOXINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Pyridoxine Hydrochloride 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 Pyridoxine Hydrochloride approved in United States?
Yes. FDA authorised it on 14 August 1972; FDA authorised it on 13 February 1974; FDA authorised it on 9 March 1983.
Who is the marketing authorisation holder for Pyridoxine Hydrochloride in United States?
FRESENIUS KABI USA holds the US marketing authorisation.