Generic drugs are pharmaceutically equivalent to pre-existing brand-name drugs and are also known as reference listed drugs (RLDs). A generic drug must have the same active ingredients, dosage form, strength, route of administration, and bioequivalence as the RLD. This means there should be no difference in the rate or extent of absorption of the active ingredient. Bioequivalence between generic and brand-name drugs that is demonstrated through in vivo and/or in vitro testing must ensure accuracy, sensitivity, and reproducibility. Marketing generic drugs requires the submission of an Abbreviated New Drug Application (ANDA) to the FDA.
Atorvastatin calcium (used to manage high cholesterol) and escitalopram oxalate (used to treat anxiety and depression) are examples of generic versions of the brand name drugs Lipitor and Lexapro, respectively. The Orange Book Database contains information on all FDA-approved drug products as well as patent and exclusivity information. It consists of four main parts including The Prescription Drug Product List, The OTC Drug Product List, The Drug Products with Approval under Section 505 of the FD&C Act Administered by the Center of Biologics Evaluation and Research List, and The Discontinued Drug Product List.