FDA orange book : approved drug products with therapeutic equivalence evaluation (annual edition)

Resource Information

The work FDA orange book : approved drug products with therapeutic equivalence evaluation (annual edition) represents a distinct intellectual or artistic creation found in Biddle Law Library - University of Pennsylvania Law School. This resource is a combination of several types including: Work, Language Material, Continuing Resources.

Label

FDA orange book : approved drug products with therapeutic equivalence evaluation (annual edition)

Title remainder

approved drug products with therapeutic equivalence evaluation (annual edition)

Title variation

• Approved drug products with therapeutic equivalence evaluation (orange book)
• Approved drug products with therapeutic equivalence evaluation (annual edition)

Contributor

• United States, Food and Drug Administration

Issuing body

• United States, Food and Drug Administration

Subject

• United States.
• Drugs -- Bioavailability
• Drugs -- Catalogs
• Drugs -- Therapeutic equivalency
• Electronic books
• Medical care -- United States
• Pharmaceutical services insurance
• United States, Food and Drug Administration -- Rules and practice

Genre

• Catalogs
• Electronic books
• Rules and practice

Language

eng

Summary

The publication, Approved drug products with therapeutic equivalence evaluations (the List, commonly known as 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 Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., phenobarbital tablets]) 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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act

Member of

• LEXIS (Information retrieval system)

Cataloging source

NjRocCCS

Characteristic

updating web site

Entry convention

integrated entry

Frequency

annual

LC call number

RM301.45

LC item number

.F33

Nature of contents

dictionaries

Original alphabet or script of title

basic roman

Regularity

regular