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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...
Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: druginfo@fda.hhs.gov. Current through June 2024 ....
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).
Mar 8, 2022 · What Is the Orange Book? The Orange Book is the FDA's official register of drugs that the agency has deemed to be safe and effective, as well as any patents covering those drugs and regulatory exclusivities to which they may be entitled. It contains listings of: Brand-name drugs for which NDAs have been approved
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
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.
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ...
The FDA offers an Orange Book searchable database. The Orange Book consists of the Patents, Products, and Exclusivity data files. The documentation describes the data fields in each file.
