《AIroval Package for》.pdf

CENTER FOR DRUG EVALUATION AND RESEARCH AIroval Package for: APPLICATION NUMBER: 12-827/8017 Trade Name: Robinul Robinul Forte Tablets Generic Name: (glycopyrrolate) Sponsor: A.H. Robins Company Approval Date: February 22,1979 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 12-827/8017 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Approvable Letter X Labelin~ Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review( s) Chemistry Review(s) X Environmental Assessment Pharmacolo2Y Review(s) Statistical Review(s) . Micro biolo2Y Review( s) Clinical Pharmacolo2Y lBiopharmaceutics Review ( s) Risk Assessment and Risk Miti~ation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document( s) X CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 12-827/8017 APPROVAL LETTER fE8221919 NOA12~827IS,..017 A..ll .. AQb1nsCøilJiariy Attentiø1H. . frilJI~esAaroe .1211Sle~nd AVenue. .. ~1fellln(m€lVll1:nia 23atIO twarMh$wAaròe.: Plell~~ J~ef~) .tt. Y~lVJ,Kt!øfJl-e~tal i.new .(irugappli~Rti()nøfJtli.yl()t .1~78, s~linftted