A federal application to sell or market a generic drug in the US under Section 505(j) of the Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)). The application is abbreviated in that it does not need to include the human clinical data required in a new drug application. The abbreviated new drug application (ANDA) instead must show that the generic drug has the same active ingredient as and is bioequivalent to the innovator drug.

The ANDA must show that the proposed generic drug is the same as the innovator drug in:

The ANDA must also include one or more certifications regarding any patent listed in the Orange Book that covers the innovator drug. This may include a certification that the patent is invalid or will not be infringed by the ANDA applicant's sale of the proposed generic product (Paragraph IV certification), which may trigger a patent infringement suit.

For more information, see Practice Note, Hatch-Waxman Act: Overview.