Guideline

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Changes to an Approved NDA or ANDA, Questions and Answers
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122871.pdf
Origin/Publisher:	Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20856, Tel. 301 827 4573, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:	This document provides questions and answers relating to the guidance on 'Changes to an Approved NDA or ANDA'
Document Type:	Guidance for Industry