How to Cite the Exact FDA Orange Book Edition and Supplement

The FDA’s Orange Book is not one undated file you can point to generically — it has a precise, two-part address. The current volume identifies itself on its own cover as “CUMULATIVE SUPPLEMENT 7” dated “July 2026,” supplementing the “46th EDITION” of “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS” (source). So a reader can name one exact version the same way the document names itself: 46th Edition, Cumulative Supplement 7, July 2026.

Blank medicine bottle, folded unmarked card, neutral folders, and a magnifying lens. — Illustrative record-reading guide for drugs and devices coverage; it contains no factual claim or record data.

This original record-reading guide is a general reading aid, not cited evidence. It does not depict a source record; the article text and source links provide the facts.

Key points

The current cumulative supplement’s cover states “CUMULATIVE SUPPLEMENT 7” and “July 2026” (source).
That supplement updates the “46th EDITION” of “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS” (source).
FDA’s preface page for this edition is titled “PREFACE TO FORTY SIXTH EDITION” and states “Content current as of: 01/15/2026” (source).
FDA discloses its own monthly supplement publishing-cadence goal in the cumulative supplement itself (source).
FDA describes the publication’s core purpose as identifying “drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA)” (source).

The two-part citable address

The Orange Book — formally “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS” — is published as a numbered Annual Edition, then kept current between annual editions by numbered monthly Cumulative Supplements. The document currently available states, on its own cover, both halves of that address at once: “46th EDITION” and “CUMULATIVE SUPPLEMENT 7,” dated “July 2026” (source). That means the full, citable name of this specific version is “46th Edition, Cumulative Supplement 7, July 2026” — not simply “the Orange Book,” and not simply “Supplement 7” without the edition it supplements.

What FDA’s cover page states

Quoting directly from the document’s own cover: “APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS,” “46th EDITION,” “CUMULATIVE SUPPLEMENT 7,” “July 2026” (source). These four elements together are the version’s full self-declared identity — the way a reader would cite this exact document rather than “the Orange Book” as a generic, undated reference.

What FDA’s preface page states

FDA’s separate preface page for the current annual edition is titled “PREFACE TO FORTY SIXTH EDITION” and states “Content current as of: 01/15/2026” (source). The preface page’s own “content current as of” date is distinct from the monthly cumulative supplement’s cover date discussed above — the preface describes the annual edition’s own content currency, not the supplement.

The supplement’s own publication-cadence goal

The cumulative supplement discloses its own intended update schedule directly: “The CS monthly update publish goal is by the end of the following month’s second work week (e.g., November’s supplement will be updated by the end of the second full work week in December).” (source). In other words, FDA’s own stated goal is to publish each month’s cumulative supplement by the end of the second full work week of the following month.

What the Orange Book identifies

FDA’s own description of the publication states that it “identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA)” (source).

What this article does not answer

This article only settles how to name and cite one exact version of the Orange Book — its Annual Edition number, its Cumulative Supplement number and month/year, and the supplement’s disclosed publishing-cadence goal. It does not identify, describe, or make any claim about a particular drug product listed inside the Orange Book. It does not explain what a therapeutic-equivalence code means for a particular use, and it does not make a substitution or interchangeability judgment about a medication. It also does not make any statement about whether a drug is safe or effective, dosing, or a decision to start, stop, or continue a medication.