Electronic Orange Book
Electronic Orange Book

Author:

Publisher:

Published: 1999

Total Pages: 0

ISBN-13:

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Presents a directory of approved drug products with therapeutic equivalence evaluations, provided by the U.S. Food and Drug Administration (FDA). Allows users to search via active ingredient, proprietary name, application number, or applicant holder.

Approved Drug Products with Therapeutic Equivalence Evaluations
Approved Drug Products with Therapeutic Equivalence Evaluations

Author: Barry Leonard

Publisher:

Published: 2005-11

Total Pages: 1014

ISBN-13: 9781422302071

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Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multi-source prescription drug products.