FDA — authorised 17 June 2009
- Application: NDA022165
- Marketing authorisation holder: ASSERTIO SPECLTY
- Local brand name: CAMBIA
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA authorised Diclofenac Potassium for Oral Solution on 17 June 2009
Yes. FDA authorised it on 17 June 2009.
ASSERTIO SPECLTY holds the US marketing authorisation.