PALIPERIDONE

I3 PHARMS obtained FDA approval for paliperidone (NDA 205402), establishing an initial product record in the Orange Book database.

I3 Pharms received FDA approval for paliperidone (NDA 205402, supplement 002).

I3 Pharms received FDA approval for a new paliperidone product (NDA 205402, Supplement 003).

I3 Pharms received FDA approval for a new paliperidone product formulation under NDA 205402, supplement 004.