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Glossary Terms

Abbreviated New Drug Application

An application containing data about a generic drug, which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product (FDA). ANDA is regulated under 21 CFR §314.98. The application for approval of a generic drug is not as voluminous as a NDA because the safety and efficacy has been established by the reference drug.

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