FDA — authorised 26 August 2005
- Application: ANDA077203
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
FDA authorised Questran on 26 August 2005
Yes. FDA authorised it on 26 August 2005; FDA authorised it on 26 August 2005; FDA has authorised it.
PH HEALTH holds the US marketing authorisation.