WebDrug Databases. Orange Book Home. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Additional information and resources for the Orange Book. We've updated...
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Approved Drug Products with Therapeutic Equivalence Evaluations
WebOct 13, 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.
WebMar 8, 2023 · Downloadable Data Files for the Orange Book. The compressed (.ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde (~)...
WebThe Orange Book has long been a reliable resource for information about FDA-approved drugs. The electronic availability of the Orange Book brings this valuable tool to the web for...
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Approved Drug Products with Therapeutic Equivalence Evaluations
WebThe DrugPatentWatch website offers a "Free DrugPatentWatch Orange Book PDF Library" from which the public can download digital copies of every FDA Orange Book, from the 1st Edition in 1980 to the most recent (as of 2020).
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Electronic Orange Book | Clinical Pharmacy and Pharmacology
WebThe FDA "Orange Book" of Approved Drug Products, with Therapeutic Equivalence Evaluations , now in its 19th edition (US Government Printing Office), is available electronically at http://www.fda.gov/cder/ob/default.htm. This reference book lists all drug products approved by the FDA.
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Approved Drug Products with Therapeutic Equivalence Evaluations
WebThe Orange Book "identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface .)" The FDA offers an Orange Book searchable database.
WebNov 1, 2014 · The Orange Book, formally titled Approved Drug Products With Therapeutic Equivalence Evaluations, is a comprehensive list of approved drug products published by the FDA. It is widely accepted as the authoritative source for determining therapeutic equivalence among multisource drug products.
WebApr 25, 2021 · Orange Book. Metadata Updated: April 25, 2021. The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides consumers timely updates on these products. In addition to these products (fo. Access & Use …
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Listing of Patent Information in the Orange Book; Establishment …
WebMar 16, 2021 · SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments” that appeared in the Federal Register of June 1, 2020.
