2025年1月10日 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.

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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...

2023年3月8日 · 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, …

How to determine what drugs are approved in the United States by the FDA? The FDA's Orange Book identifies approved drug products FDA has draft guidance explaining that certain …

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 …

2024年12月27日 · For drug manufacturers, the Orange Book’s information on a drug’s patents and regulatory exclusivities can be critical to whether and when generic competition occurs.

2022年7月26日 · For newer users, FDA explains that the Orange Book has four parts: Prescription Drug List – a list of all approved marketed prescription drug products and their …

2025年1月15日 · How 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 …

The 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 …