Abbreviated new drug application (ANDA) number
A unique identifier the FDA assigns to an approved generic drug application. The ANDA proves the generic matches a brand-name reference product in dosage, strength, and intended use, enabling marketing without repeating original clinical trials.
What does an Abbreviated new drug application (ANDA) number mean?
An Abbreviated new drug application (ANDA) number is the unique identifier the U.S. Food and Drug Administration assigns to an approved application for a generic drug. The application is called abbreviated because the sponsor does not have to repeat the costly clinical trials performed for the original brand-name product; instead it demonstrates that the generic is equivalent to a previously approved reference drug.
To earn approval and its ANDA number, the generic must match the brand-name reference in active ingredient, dosage form, strength, route of administration, and intended use, and it must show bioequivalence. The number then serves as the official reference for that approved generic product in FDA records.
Why is the ANDA number important?
The ANDA number is the regulatory proof that a generic drug is an FDA-sanctioned substitute for its brand-name counterpart, which is what allows pharmacies and prescribers to dispense lower-cost equivalents with confidence. Generics approved through this pathway are a primary mechanism for controlling drug spending across the health system.
In drug databases, supply chain records, and pricing analyses, the ANDA number provides a precise way to identify a specific approved product and tie it back to its reference listing. This traceability supports formulary decisions, reimbursement determinations, and recall management when a particular product is implicated.
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