Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) is a request submitted to the U.S. Food and Drug Administration (FDA) to get approval for a generic version of a previously approved brand-name drug. The ANDA process allows generic drug manufacturers to demonstrate that their product is equivalent to the original in dosage, strength, and quality, without needing to repeat the extensive clinical trials that the original drug underwent. This helps lower drug costs and increases access to medications, while ensuring the generic product is safe and effective for consumers.