Chlorhexidine gluconate topical spray
Executive SummaryANDA 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.
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