ANDA Process: What It Is and How Generic Drugs Get Approved

When you pick up a generic version of your prescription, you’re seeing the result of the ANDA process, the Abbreviated New Drug Application pathway the U.S. Food and Drug Administration uses to approve generic medications. Also known as the Abbreviated New Drug Application, it’s the system that lets safe, effective generic drugs reach the market without repeating expensive animal and human trials already done by the brand-name maker. This isn’t a loophole—it’s a carefully designed rule that saves patients billions every year.

The FDA, the U.S. agency responsible for protecting public health by ensuring the safety and effectiveness of drugs doesn’t require generic makers to prove the drug works again. Instead, they must show their version is identical in active ingredient, strength, dosage form, and how it’s absorbed by the body. This is called bioequivalence. If a generic pill delivers the same amount of medicine into your bloodstream as the brand-name version, the FDA approves it. That’s why your generic metformin, lisinopril, or azithromycin works just like the name-brand version—but costs 80% less.

The Abbreviated New Drug Application, the formal submission to the FDA to get a generic drug approved includes detailed info on manufacturing, quality control, and stability testing. It’s not a quick form—it’s a thick dossier that takes months to prepare and review. But it’s still far faster and cheaper than the 10–15 years and $2.6 billion it takes to bring a new drug to market. That’s why you see so many generics after a brand-name patent expires. The ANDA process is the engine behind 90% of prescriptions filled in the U.S. today.

Some people worry generics aren’t as good. But the FDA holds them to the same standards as brand-name drugs. The same factories sometimes make both. The difference? Price. And the ANDA process makes that possible. If you’ve ever saved money on your cholesterol med, antibiotic, or antidepressant, you’re benefiting from this system.

Behind every generic you take is a chain of regulation, testing, and oversight that keeps you safe while keeping costs down. The ANDA process doesn’t cut corners—it cuts waste. And in a world where drug prices keep rising, it’s one of the few things working in your favor.

Below, you’ll find real-world examples of how this system affects the medications you use—from how azithromycin and modafinil became affordable, to how side effects are tracked even after a drug hits the market. These aren’t abstract rules. They’re the reason your prescriptions are within reach.