FDA — authorised 23 November 1983
- Application: NDA018831
- Marketing authorisation holder: HOSPIRA
- Local brand name: TRACRIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Tracrium Preservative Free in United States
FDA authorised Tracrium Preservative Free on 23 November 1983
Marketing authorisations
FDA — authorised 17 February 2012
- Application: ANDA091489
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 18 October 2012
- Application: ANDA090761
- Marketing authorisation holder: HOSPIRA INC
- Status: approved
FDA — authorised 26 July 2018
- Application: ANDA090782
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
FDA — authorised 26 July 2018
- Application: ANDA091488
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
FDA — authorised 26 July 2018
- Application: ANDA206010
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
Tracrium Preservative Free 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 Tracrium Preservative Free approved in United States?
Yes. FDA authorised it on 23 November 1983; FDA authorised it on 17 February 2012; FDA authorised it on 18 October 2012.
Who is the marketing authorisation holder for Tracrium Preservative Free in United States?
HOSPIRA holds the US marketing authorisation.