FDA — authorised 11 July 1994
- Application: NDA020015
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 N-Acetyl-Tyrosine in United States
FDA authorised N-Acetyl-Tyrosine on 11 July 1994
Marketing authorisations
FDA — authorised 21 August 2002
- Application: NDA020041
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
N-Acetyl-Tyrosine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is N-Acetyl-Tyrosine approved in United States?
Yes. FDA authorised it on 11 July 1994; FDA authorised it on 21 August 2002.
Who is the marketing authorisation holder for N-Acetyl-Tyrosine in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.