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Orange Book: Approved Drug Products with Therapeutic Equivalence
https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
WebPlease send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: [email protected]. Current...
DA: 14 PA: 43 MOZ Rank: 66
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Approved Drug Products with Therapeutic Equivalence Evaluations
https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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.
DA: 19 PA: 28 MOZ Rank: 13
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Electronic Orange Book | FDA
https://www.fda.gov/drugs/fda-drug-info-rounds-video/electronic-orange-book
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...
DA: 94 PA: 67 MOZ Rank: 37
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Orange Book Data Files | FDA - U.S. Food and Drug Administration
https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
WebMar 8, 2023 · Orange Book Data Files. Drug Approvals and Databases. Orange Book Data Files. Share. Downloadable Data Files for the Orange Book. The compressed (.ZIP) data file unzips into three...
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Orange Book Preface | FDA - U.S. Food and Drug Administration
https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface
WebJan 24, 2023 · 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.
DA: 25 PA: 53 MOZ Rank: 72
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FDA Drug Topics: Orange Book: Frequently Asked …
https://www.fda.gov/media/143766/download
WebOct 31, 1980 · The Orange Book is an FDA publication mandated under section 505(j)(7)(A) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) which: provides a listing of drugs approved as safe and...
DA: 28 PA: 86 MOZ Rank: 86
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Approved Drug Products with Therapeutic Equivalence Evaluations
https://en.wikipedia.org/wiki/Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations
WebApproved 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 …
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Frequently Asked Questions on The Orange Book | FDA
https://www.fda.gov/drugs/drug-approvals-and-databases/frequently-asked-questions-orange-book
WebHow do I obtain the Orange Book? How do I use the Electronic Orange Book to find approved generic drugs? I want drug information not found in the Orange Book. How do I go about getting...
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Generic Drugs and The Orange Book - U.S. Food and Drug …
https://www.fda.gov/media/94801/download
WebAbout the Orange Book. Fulfills a mandate to list drug products approved as safe and effective under section 505(c) of the Federal Food, Drug, and Cosmetic Act. Contains information with...
DA: 61 PA: 72 MOZ Rank: 71
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From Our Perspective: The Orange Book at 40: A valued FDA …
https://www.fda.gov/drugs/our-perspective/our-perspective-orange-book-40-valued-fda-resource-continually-enhanced-user-input
WebThe Orange Book is the only official source for therapeutic equivalence evaluations and reference listed drug (RLD) data for FDA-approved generic and brand-name drugs.
DA: 37 PA: 26 MOZ Rank: 53