FDA-2025-P-3542

Requests that FDA assign a Therapeutic Equivalence Evaluation Code for the following five strengths of the company’s ERZOFRI (paliperidone palmitate) Extended-release Injectable Suspension drug products (the “ERZOFRI TE Strengths”): (1) 39 mg/0.25 mL (39 mg/0.25 mL) (hereinafter, “39 mg/0.25 mL”); (2) 78 mg/0.5 mL (78 mg/0.5 mL) (hereinafter, “78 mg/0.5 mL”).