Guideline

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ANDA's: Impurities in Drug Substances
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172002.pdf
Origin/Publisher:	Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/
Content:	This guidance provides recommendations for information in ANDAs and supporting DMFs on the identification and qualification of impurities in drug subtances.
Status:	Draft
Document Type:	Guidance for Industry