Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation

Issue Date: March 13, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final

Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation

This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates the practice of tablet splitting. )

Download the Guidance Document

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