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Abbreviated New Drug Application (ANDA)

by mlscience on Sat, 09/14/2024 - 09:42

An abbreviated new drug application (ANDA) contains information submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. It must prove that a proposed generic medicine is equivalent to an existing approved reference-listed drug (RLD) in terms of safety, efficacy, and quality.

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