Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs guidance is intended to assist applicants who are submitting abbreviated new drug 17 applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called 19 topical products.² Because of the complex route of delivery associated with these products, 20 which are typically locally acting, and the potential complexity of certain formulations, topical 21 products (other than topical solutions) are classified as complex products.³