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# FDA Guide on Drug Proprietary Name Submissions
- URL: https://www.fdaweb.com/fda-guide-on-drug-proprietary-name-submissions/
- Published: 2016-04-05T12:00:00.000Z
- Updated: 2026-09-14T20:52:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135288

> FDA has posted a[ guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068.pdf?ref=fdaweb.com) on “Contents of a Complete Submission for the Evaluation of Proprietary Names” that describes the information it uses to evaluate proposed proprietary names for drugs and biological products. The agency says the document is intended to assist industry when submitting complete submission packages used to assess:   
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> 1\. the safety aspects of a proposed proprietary name*,* to reduce medication errors, and  
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> 2\. the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labelingand promotion using our traditional review methods.   
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> FDA says the guidance does not describe the methods used for evaluating proposed proprietary names, nor does it describe information needed to evaluate proposed proprietary names under an ongoing, voluntary two-year pilot program.