FDA — authorised 12 July 2002
- Application: ANDA040256
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
FDA authorised Multiple-Visit-"Corticosteroid Paste" on 12 July 2002
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 July 2002; FDA authorised it on 8 April 2005; FDA authorised it on 25 April 2016.
PH HEALTH holds the US marketing authorisation.