21 CFR 314.94 - Content and Format of an Abbreviated Application

What it says

An abbreviated new drug application (ANDA) must contain the information that supports approval of a generic drug, including the basis for submission, conditions of use, active ingredients, route of administration, dosage form and strength, bioequivalence data, labeling that is the same as the reference listed drug with permitted differences, chemistry, manufacturing and controls information, samples as requested, and patent certifications.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A generic must show that it is the same as the reference product in key respects and bioequivalent to it.
• Manufacturing and controls information is a large part of the application, so site and process details must be accurate.
• Patent certifications affect when approval can be granted.

What FDA inspectors look for

• Whether the data in the application match what is done at the site.
• Whether the bioequivalence studies were conducted and reported properly.
• Whether commitments in the application are followed.

Related regulations