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5 Trade Name TRADENAME Sponsor Bausch Lomb Submission Type Original NDA submission Amendment OCP Reviewer Gerlie Gieser PhD Team Leader Philip Colangelo PharmD PhD Table of Contents I. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER 202872Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW S NDA 202-872 N-000 Submission Date 29 November 2011 20 January 2012 Drug Product etabonate ophthalmic gel 0. 3 Pharmacokinetics The systemic exposure to etabonate following ocular...
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