Approved Prescription Drug Products With Therapeutic Equivalence Evaluations

FDA Orange Book 32nd Edition - 2012 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Accompanied by supplements.

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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 multisource prescription drug products.

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.

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 multisource prescription drug products.