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FDA Guidance for Industry: NDAs: Impurities in Drug Substances (Feb. 2000)


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for industry
Guideline issued by CDER (FDA) on necessary identification and qualification for NDAs and drug master files of impurities in active substances manufactured by chemical synthesis (monographed and non-monographed drug substances)

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