Identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and 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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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 multisource prescription drug products.