Chlorhexidine gluconate topical spray
Executive Summary
ANDA suitability petition for the 0.5% product was approved on Aug. 19. FDA's letter to Washington, D.C.-based law firm Arent, Fox, Kintner, Plotkin & Kahn states that the change in dosage form "does not pose questions of safety and effectiveness." The ANDA petition cites stuart's Hibistat Topical solution 0.5% as the reference product.