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13 Οκτ 2023 · Search the Orange Book Database. Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.
- Drug Approvals and Databases
Additional topics include: approved REMS, drug shortages,...
- Orange Book Patent Listing Dispute List
N/A N/A 4/21/2023 4/21/2023 No Orange Book Changes...
- Orange Book Preface
Preface to Approved Drug Products with Therapeutic...
- Approved Drug Product List
clindamycin phosphate in 5% dextrose in plastic container RX...
- Orange Book Annual Edition
Explore the U.S. Food and Drug Administration's official...
- Drug Approvals and Databases
Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be, relevant terms and codes, user responsibilities and more.
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 (Hatch-Waxman Act).
The Orange Book identifies (1) drug products approved by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and (2) patent and exclusivity information related to approved drug...
29 Δεκ 2015 · It is also the authoritative source of information on the therapeutic equivalence of drug products. The orange book consist of five main sections: an introduction, a “how to use” section, the drug product lists, appendices and a patent and exclusivity information addendum.
Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug
14 Μαρ 2011 · The Orange Book is available on the FDA’s Web site (www.fda.gov) under the Drugs link in the Spotlight section. A simple method of using the Orange Book for identifying therapeutically equivalent prescription medications involves searching by active ingredient.
