Notes
NDMA = N-nitrosodimethylamine; CDER = Center for Drug Evaluation and Research.
Reference
Woodcock J. Statement on new testing results, including low levels of impurities in ranitidine drugs. Internet Document : 1 Nov 2019. Available from: URL: https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
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Impurity testing of ranitidine products: US FDA update. Reactions Weekly 1779, 1 (2019). https://doi.org/10.1007/s40278-019-71265-z
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DOI: https://doi.org/10.1007/s40278-019-71265-z