Direct Max 3-in-1 (Apomorphine, Sildenafil, & Tadalafil) as a combined formulation is not FDA-approved.
It is a compounded medication prepared by a licensed U.S. compounding pharmacy based on a prescription from a licensed healthcare provider.
While sildenafil and tadalafil are active ingredients found in certain FDA-approved medications, compounded products differ from commercially manufactured drugs and may vary in formulation, dosing, and supporting evidence.

