Fda orange book use codes

Codes beginning with a signify the product is deemed therapeutically equivalent to the reference product for the category. And, oh, by the way, the new regulations will result in other new orange book firsts as fda is required to make several changes to the orange book, including identifying patents for which a dispute has been submitted by an interested party. Refer to the eob home page preface for discussion and definitions of the te code and reference listed drug rld. Food and drug administration fda has approved as both safe and effective. Finally, the orange book lists patents that are purported to protect each drug. Approved drug products with therapeutic equivalence. Use codes provide the mechanism that nda holders use to tell the fda and the world how their orange booklisted method patents relate to their approved drug indications. A major focus of the rule, which goes into effect on december 5, 2016, is patent use codes. The electronic availability of the orange book brings this valuable tool to the web for healthcare.