Updated Guidance for Naming of Drug Products Containing Salt Drug Substances

Updated Guidance for Naming of Drug Products Containing Salt Drug Substances

On June 17, 2015, the Food and Drug Administration (FDA) released guidance for its “Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations. This guidance replaces the draft that was released in December of 2013. To obtain a copy of the guidance please visit the FDA website at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm379753.pdf

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