Which application must generic drug makers document to demonstrate bioequivalence to brand-name products?

The Abbreviated New Drug Application (ANDA) is the correct choice because it is specifically designed for generic drug manufacturers to demonstrate that their products are bioequivalent to the brand-name counterparts. Bioequivalence means that the generic product delivers the same amount of active ingredient into a patient's bloodstream in the same amount of time as the brand-name drug, ensuring similar efficacy and safety profiles.

This streamlined application process allows for the approval of generic drugs without the need for the extensive clinical trials usually required for a New Drug Application (NDA), which is meant for brand-new drugs seeking market approval. The Investigational New Drug Application (IND) is utilized for drugs that are still in the exploration phase and require clinical trials to assess safety and efficacy before applying for market approval. The Supplemental New Drug Application (sNDA) is used for changes to an already approved drug, not for introducing a generic version.

Thus, the ANDA is essential for generic drug makers to affirm bioequivalence, lower drug costs, and increase accessibility to medications.