The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Axiron Topical Solution, 30 mg per pump actuation, of Eli Lilly and Company (Lilly).

Testosterone Topical Solution USP, 30 mg per pump actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypoqonadisrn (congenital or acquired).