FDA's Generic Drug Approval Process: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, First Session, Part 4U.S. Government Printing Office, 1989 |
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Agency American Therapeutics Amitriptyline ANDA's Voluntarily Withdrawn Ashok Patel ATI's audits August 29 Barr Laboratories Barr's believe bioequivalence biostudy BLILEY Bolar Brancato brand name Chairman Charles Chang client Clonidine Clorazepate Clorazepate Dipotassium committee communications consultant corporate counsel Diazepam Dilip Shah DINGELL Director DISTRICT OF MARYLAND Division documents Drug Administration drug applications drug companies drug firms drug industry drug manufacturers drug products Dyazide false statements FDA employees FDA-Relations Action Plan FDA's Finelli FIRM ANDA Food and Drug fraud fraudulent gratuities Hill and Knowlton Hydrochloride Tablets Hydrochlorothiazide inspection involved issues JORDAN Kip Schwartz Kletch LENT manufacturing practices MCMILLAN MICHELS NAVAZIO Norris Oxazepam pharmaceutical Pharmagen PharmaKinetics problems Quad recall request Rockville samples Sturm submitted Superpharm Tablets USP testimony tion Trazodone Triamterene U.S. Attorney Vegesna Vitarine VOGEL WILLCOX withdraw Withdrawn Since 5/1/89 WYDEN York