ANDA

An Abbreviated New Drug Application (ANDA) is a streamlined process that pharmaceutical companies use to get approval from the U.S. Food and Drug Administration (FDA) to market a generic version of an already approved brand-name drug. Instead of submitting all safety and effectiveness data anew, companies demonstrate that their generic is identical in dosage, strength, method of production, and performance. The goal is to provide more affordable medication options by ensuring generics are safe, effective, and bioequivalent to the original drug, ultimately increasing access to essential medicines.