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Oct 13, 2023 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.
Mar 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 (~)...
The 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...
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 is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP? U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/RESULTS_PRODUCT.CFM?APPL_TYPE=N&APPL_NO=022006#21586) TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE ...
Jun 1, 2020 · In 1985, FDA added to the Orange Book a list of OTC drug products that have been approved in NDAs or ANDAs. In 1997, FDA published the Orange Book on the internet. In 2003, FDA started publishing an indicator as to whether a listed patent contains drug substance and/or drug product claims.
Jul 25, 2022 · The Orange Book identifies drug products approved by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related patent and exclusivity information. The main criteria for the inclusion of a drug product in the Orange Book are that the drug product is the subject of an approved application and that FDA has not determined the drug ...
07/08/2021 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations 1/ Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Mkt.Status Active Ingredient Proprietary Name Appl. No. Dosage Form Route Strength TE Code RLD RS Applicant Holder RX FOMEPIZOLE FOMEPIZOLE A078368 INJECTABLE INJECTION 1.5GM/1.5ML (1GM/ML) AP AMERICAN REGENT INC RX FOMEPIZOLE FOMEPIZOLE A078639 INJECTABLE INJECTION 1.5GM/1.5ML (1GM/ML)
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.
