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.

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