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GUIDANCE DOCUMENT

Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation March 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0595
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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. )

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0595.

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