FDA — authorised 5 January 2012
- Application: NDA203049
- Marketing authorisation holder: HIKMA PHARM CO LTD
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Argatroban in United States
FDA authorised Argatroban on 5 January 2012
Marketing authorisations
FDA — authorised 30 June 2014
- Application: ANDA091665
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 27 November 2018
- Application: NDA209552
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 21 January 2021
- Application: ANDA214235
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA — authorised 1 August 2023
- Application: ANDA202626
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Indication: Labeling
- Status: approved
Argatroban in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Argatroban approved in United States?
Yes. FDA authorised it on 5 January 2012; FDA authorised it on 30 June 2014; FDA authorised it on 27 November 2018.
Who is the marketing authorisation holder for Argatroban in United States?
HIKMA PHARM CO LTD holds the US marketing authorisation.