WORLD OF GENERIC DRUGS MODULE

Introduction

The Office of Generic Drugs (OGD) in FDA's Center for Drug Evaluation and Research (CDER) ensures drugs are safe and effective before approval. Generic products contain the same drug substance as brand name drugs. They are comparable to the reference-listed drug in dosage form, strength, route of administration, performance and intended use.

An abbreviated new drug application (ANDA) contains data which, when submitted to OGD, provide for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective and low cost alternative to the American public.