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1. Orange Book: Approved Drug Products with Therapeutic Equivalence
Link: https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Description: WEBOrange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Additional information and resources for the Orange Book. We've updated our mobile app! Download Orange...
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2. Approved Drug Products with Therapeutic Equivalence Evaluations
Link: https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
Description: 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.
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3. Electronic Orange Book | FDA
Link: https://www.fda.gov/drugs/fda-drug-info-rounds-video/electronic-orange-book
Description: 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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4. Orange Book Data Files | FDA
Link: https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
Description: 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 (~)...
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5. Approved Drug Products with Therapeutic Equivalence Evaluations
Link: https://en.wikipedia.org/wiki/Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations
Description: 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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6. Orange Book-Questions and Answers; Guidance for Industry; …
Link: https://www.federalregister.gov/documents/2022/07/25/2022-15831/orange-book-questions-and-answers-guidance-for-industry-availability
Description: WEBJul 25, 2022 · This guidance provides answers to commonly asked questions FDA has received from interested parties regarding the Orange Book. 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.
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7. Electronic Orange Book | Clinical Pharmacy and Pharmacology
Link: https://jamanetwork.com/journals/jama/fullarticle/1839563
Description: WEBListen to. The 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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8. THE NBER ORANGE BOOK DATASET: A USER’S GUIDE …
Link: https://www.nber.org/system/files/working_papers/w30628/revisions/w30628.rev0.pdf
Description: WEBAug 18, 2003 · In this paper, we introduce a newly digitized, open-access dataset of Orange Book records from 1985 to 2016, and provide a “user’s guide” to its opportunities and challenges for researchers.4 The dataset combines information from print editions in the early years of the Orange Book (1985–1999) with digital data in later years …
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9. Orange Book: Approved Drug Products with Therapeutic …
Link: https://downloads.regulations.gov/FDA-2016-P-1363-0003/content.pdf
Description: WEBMay 24, 2016 · Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations i· t9 A Home 3 ~ru~~a)\bases4 Oraa g 0 Book 5 rangeo :pprove rug Products w1th • Therapeutic Equivalence • Evaluations . S'earch results from the "OB_D1sc" table for query on "019329." Active Ingredient: Dosage Form;Route: Proprietary Name: Applicant: …
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10. Federal Register :: Approved Drug Products With Therapeutic …
Link: https://www.federalregister.gov/documents/2020/06/01/2020-11683/approved-drug-products-with-therapeutic-equivalence-evaluations-the-orange-book-establishment-of-a
Description: WEBJun 1, 2020 · The Orange Book is composed of four main parts: (1) The Prescription Drug Product List, which is a list of approved marketed prescription drug products with therapeutic equivalence evaluations; (2) the OTC Drug Product List, which is a list of marketed over-the-counter (OTC) drug products that have been approved in new drug …