chapter  10
14 Pages

Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)

ByRichard A. Guarino

ABBREVIATED NEW DRUG APPLICATION An abbreviated new drug application (ANDA) is specifically designed for an approval of a generic drug product. When data within an ANDA are submitted to the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), Office of Generic Drugs at 7500 Standish Place, Rockville, Maryland, U.S., the applications are reviewed and approved from that division. On approval of the application, the applicant may manufacture and market the generic drug product with the purpose of providing the American consumer with a safe, effective, and low-cost alternative of a brand name drug.