Orange Book 46th Edition
Summary
The FDA has published the 46th edition of the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). The Orange Book is the authoritative FDA reference listing approved prescription drug products, including patent and exclusivity information used by generic drug manufacturers, pharmacy benefit managers, and healthcare payers to assess therapeutic equivalence.
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GovPing monitors Regs.gov: Food and Drug Administration for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 367 changes logged to date.
What changed
The FDA released the 46th edition of the Orange Book, an annual consolidated reference of the agency's approved prescription drug product listings. The Orange Book includes product approval dates, patent and exclusivity information, and therapeutic equivalence evaluations.\n\nGeneric drug manufacturers, pharmacists, and healthcare payers rely on the Orange Book for ANDA filing assessments and formulary decisions. The publication is updated monthly online and consolidated annually into a printed edition.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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