U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

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. )


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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