FDA — authorised 24 July 2018
- Application: ANDA207630
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA authorised Preservative on 24 July 2018
Yes. FDA authorised it on 24 July 2018; FDA authorised it on 19 April 2024; FDA has authorised it.
EUGIA PHARMA holds the US marketing authorisation.