Orange book codes the orange book codes supply the fdas therapeutic equivalence rating for applicable multisource categories. The fda keeps a list known as the orange book of every approved therapeutic equivalent. On march 23, 2020, fda removed from the orange book the listings for. Approved drug products with therapeutic equivalence evaluations orange book. Approved drug products with therapeutic equivalence. The therapeutic equivalence evaluations in the orange book reflect fdas application of specific criteria to the multisource prescription drug products listed in the orange book and approved under. The publication, approved drug products with therapeutic equivalence evaluations the list, commonly known as the orange book, identifies drug products approved on the basis of safety and.
The fda orange book of approved drug products, with therapeutic equivalence evaluations, now in its 19th edition us government printing office. Approved drug products with therapeutic equivalence evaluations orange book short description. The publication approved drug products with therapeutic equivalence evaluations the list, commonly known as the orange book identifies drug products. It allows users to determine quickly whether the agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products and provides additional information on the basis. Approved drug products with therapeutic equivalence evaluations. Approved drug products with therapuetic equivalence evaluations.
Electronic orange book clinical pharmacy and pharmacology. More in approved drug products with therapeutic equivalence evaluations orange book. Office of generic drugs presents a database of approved drug products with therapeutic equivalence evaluations, provided by the u. Codes beginning with a signify the product is deemed therapeutically equivalent to the reference product for the category.
The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and. One prescription example would be combined oral contraception, also know as the birth control pill. Approved drug products food and drug administration. The orange book uses a coding system to describe the therapeutic equivalence evaluations of drug products being listed.
Approved drug products with therapeutic equivalence evaluations, commonly known as the orange book, is a publication produced by the united states food. Approved drug products with therapeutic equivalence evaluations, commonly known as the orange book, is a publication produced by the united states food and drug administration fda, as required by the drug price and competition act hatchwaxman act the hatchwaxman act was created to strike a balance between two competing policy interests. Therapeutic equivalence an overview sciencedirect topics. The history, purpose, and content of fdas approved drug products with therapeutic equivalence evaluations the orange book are described. A combination of both pfa and nfa conclusions, the orange book began to serve as a. An overview of the fda publication approved drug products with. Orange book fr safety or effectiveness determinations list. The official name of fdas orange book is approved drug. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug. Please see the reference listed drugs by anda reference standard list on the orange book page.