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Abbreviated Application

The type of application submitted to the FDA for approval of a generic drug, which is 'abbreviated' because it relies on the safety and effectiveness findings of a previously approved brand-name drug.

Listed Drug

The brand-name drug that has already been approved by the FDA and serves as the reference product for generic drug applications.

Inactive Ingredients

Components of a drug product that are not the active medicinal substance but are necessary for manufacturing, stability, or to aid in the drug's delivery, like fillers, binders, or coloring agents.

Qualitatively and Quantitatively the Same

Meaning that a generic drug has the exact same inactive ingredients (qualitatively) and in the exact same amounts (quantitatively) as the listed brand-name drug.

Controlled Correspondence

A formal, written communication process between drug manufacturers and the FDA to ask specific questions about drug development, regulatory requirements, or scientific issues.

Bioequivalence

The state where two drugs, usually a brand-name and a generic, deliver the same amount of active drug to the body at the same rate and extent, meaning they work in essentially the same way.