FDA regulatory

New Drug Application (NDA)

Definition

The application through which a sponsor seeks FDA approval to market a new brand-name drug.

An NDA carries the full preclinical and clinical evidence package. Products approved this way appear in FDA data with marketing category NDA and an application number beginning NDA.

The application number, not the NDC, is what links a brand to its generics: an ANDA references the NDA it is bioequivalent to.

Abbreviated New Drug Application (ANDA)The application for a generic drug, which relies on the brand's safety and efficacy data and proves bioequivalence instead.Definition 505(b)(2)A hybrid application pathway that relies partly on data the applicant did not generate.Definition Marketing categoryThe FDA field stating the legal basis on which a product is marketed — NDA, ANDA, BLA, OTC monograph and others.Definition Orange BookThe FDA publication listing approved drug products with their therapeutic equivalence evaluations and patent data.Definition

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New Drug Application (NDA)

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