Guideline

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Changes to an Approved NDA or ANDA, Revision 1
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm077097.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 FDA guideline contains important information for changes.
Document Type:	FDA Guidance for Industry