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Federal Food, Drug, and Cosmetic Act

The foundational law that gives the FDA its authority to regulate food, drugs, cosmetics, and medical devices in the U.S.

Abbreviated Application

A type of application submitted to the FDA for approval of a generic drug. It's 'abbreviated' because it doesn't require new clinical trials to prove safety and effectiveness, only that it's bioequivalent to an already approved drug.

Inactive Ingredients

Components of a drug that are not the active medicinal substance itself. They help with things like drug delivery, stability, taste, or appearance (e.g., fillers, binders, colors).

Listed Drug

The brand-name reference drug that a proposed generic drug is compared against to ensure it is therapeutically equivalent.

Bioequivalence

Meaning that two drugs, when given in the same dose, deliver the same amount of active ingredient to the body in the same amount of time, resulting in the same therapeutic effect.

Qualitatively and Quantitatively the Same

Referring to inactive ingredients: 'Qualitatively' means they contain the exact same types of inactive ingredients, and 'Quantitatively' means they contain the exact same amounts (concentrations) of those inactive ingredients.