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3 Trade Name OCP Reviewers Ryan P. Owen Ph. D. OCP Team Leader Charles Bonapace Pharm.D. OCP Division DCP4 DAIOP 520 Sponsor Allergan Relevant IND s 59 408 Submission Type Code b 4 Formulation Strength s 3 mg/mL 0. CLINICAL PHARMACOLOGY REVIEW NDA 21-493 Submission Date s 3/30/2009 Drug ophthalmic solution 0. 45 mg . The dosing regimen used in adults which produced concentrations below the limit of quantification would be more than 8 times the neonatal dose. 3 of given 3 times a day the...
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