FDA — authorised 27 December 1985
- Marketing authorisation holder: SIGMA TAU
- Status: approved
🇺🇸 Carnitor in United States
FDA authorised Carnitor on 27 December 1985
Marketing authorisations
FDA — authorised 16 December 1992
- Application: NDA020182
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 29 March 2001
- Application: ANDA075567
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 15 April 2002
- Application: NDA019257
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Indication: Labeling
- Status: approved
FDA — authorised 14 August 2019
- Application: ANDA211676
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 9 December 2022
- Application: ANDA216384
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
Carnitor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Carnitor approved in United States?
Yes. FDA authorised it on 27 December 1985; FDA authorised it on 16 December 1992; FDA authorised it on 29 March 2001.
Who is the marketing authorisation holder for Carnitor in United States?
SIGMA TAU holds the US marketing authorisation.