Background of U.S. Abbreviated New Drug Application (ANDA)： ANDAs are submitted to the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which is responsible for reviewing and approving generic products. Once approved, applicants can manufacture and market generic products. These drugs, which are equivalent to the original drug in terms of quality, composition, dosage, route of administration, use, and performance, provide the American public with a safe, effective, and low-cost alternative.