FDA — authorised 17 August 1987
- Application: NDA019398
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
🇺🇸 TAURINE in United States
FDA authorised TAURINE on 17 August 1987
Marketing authorisations
FDA — authorised 7 September 1988
- Application: NDA019018
- Marketing authorisation holder: B BRAUN
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 December 1993
- Application: NDA019492
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 August 2004
- Application: ANDA075880
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
TAURINE 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 TAURINE approved in United States?
Yes. FDA authorised it on 17 August 1987; FDA authorised it on 7 September 1988; FDA authorised it on 30 December 1993.
Who is the marketing authorisation holder for TAURINE in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.