FDA regulatory

Abbreviated New Drug Application (ANDA)

Definition

The application for a generic drug, which relies on the brand's safety and efficacy data and proves bioequivalence instead.

The abbreviation is in the evidence, not the review. An ANDA product must match the reference drug in active ingredient, strength, dosage form and route, and demonstrate equivalent absorption.

Multiple ANDA holders can market the same molecule, each with its own NDC, which is why one generic drug can appear dozens of times in the NDC Directory.

New Drug Application (NDA)The application through which a sponsor seeks FDA approval to market a new brand-name drug.Definition Therapeutic equivalence codeA two-character Orange Book rating stating whether a generic is substitutable for its reference brand.Definition AB ratingThe most common therapeutic equivalence rating, meaning a generic is substitutable for the brand.Definition Orange BookThe FDA publication listing approved drug products with their therapeutic equivalence evaluations and patent data.Definition

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505(b)(2)Active ingredient Active moiety Biologics License Application (BLA)Biosimilar Boxed warning Chemical structure (CS)Dosage form

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Abbreviated New Drug Application (ANDA)

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