Tag: ANDA

What Is an ANDA? Abbreviated New Drug Application Explained

Posted By Simon Woodhead    On 25 Nov 2025    Comments(1)
What Is an ANDA? Abbreviated New Drug Application Explained

An ANDA, or Abbreviated New Drug Application, is the FDA pathway that lets generic drug makers prove their products are equivalent to brand-name drugs without repeating costly clinical trials. It's how 90% of U.S. prescriptions are filled at a fraction of the cost.