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FACTS@FDA

Facts@FDA provides up-to-date labeling information on FDA-regulated products using the Health Level Seven XML-based Structured Product Labeling (SPL) format.

FDA is now making available the content of labeling for approved prescription drugs as a single downloadable ZIP file. Not all labels are currently available in SPL. We are making SPL available as it comes to us. We hope to have labeling for all approved prescription drugs available in SPL by the end of 2006.

Health information suppliers can download available content of labeling in SPL format from this National Library of Medicine site. Drug labeling on this site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes.

The National Library of Medicine is using these files on their DailyMed web site allowing individual SPL to be viewed and downloaded.

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