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Truong details how Orange Book listings are added, updated and maintained
Summary
In a presentation, Truong, lead pharmacist for the Orange Book division, outlined the workflow for listing additions and updates, the data sources (NDA/ANDA submissions, patents, supplements and marketing-status notices), and the publication cadence (daily/semimonthly/monthly/annual).
Truong, lead pharmacist in the Orange Book division, presented an overview of how the Orange Book is maintained and why its listings matter to prescribers, pharmacists and industry. "Objective is, by the end of the session is to understand workflow behind the Orange Book entries," Truong said at the start of the presentation. The speaker framed the Orange Book as the definitive public record of marketed prescription and certain OTC drug products and explained the kinds of listing information the file contains: marketing status, proprietary name, formulation, route and strength, therapeutic code, reference listed drug or reference standard designation, current applicant holder and related metadata.
Truong recounted the Orange Book's development and legal basis, noting the publication's origins in 1979 and the FDA's 1980 final rule on therapeutic equivalence listings; the speaker said the division published its 46th edition in mid-January 2026. Truong also walked audiences through the practical consequences of listings: new line entries generally appear in the active section unless the applicant notifies the division that a product will not be marketed within 180 days of approval, in which case timely notification may exclude the product from active publication. The presentation emphasized that accurate listings affect substitution decisions, intellectual property transparency and market surveillance.
