FDA Approved Drugs: What They Are, How They're Checked, and What It Means for You
When you pick up a prescription, you’re holding a drug that went through one of the toughest reviews in the world: FDA approved drugs, medications evaluated by the U.S. Food and Drug Administration for safety, effectiveness, and quality before being sold to the public. Also known as prescription drugs cleared by the FDA, these aren’t just any pills—they’re the ones that have been tested in labs, clinical trials, and real-world use before reaching your medicine cabinet. This doesn’t mean they’re perfect, but it does mean they’ve passed a high bar.
The FDA doesn’t just approve brand-name drugs. Generic drugs, lower-cost versions of brand-name medications that contain the same active ingredient, dosage, and intended use. Also known as generic equivalents, they’re held to the same standards. How? Through something called bioequivalence, a scientific test proving a generic drug delivers the same amount of medicine into your bloodstream as the brand version. The rule? The generic must work within 80% to 125% of the original. That’s not a guess—it’s a measurable, repeatable standard. If it doesn’t meet that, it doesn’t get approved. And that’s why you can trust a generic for high blood pressure, diabetes, or antibiotics just like you would the brand name.
But approval isn’t the end of the story. The FDA keeps watching. Drugs can be pulled or flagged later if new risks show up. That’s why tools like the FDA Drugs@FDA database, the official public archive of drug approval documents, labeling, and review history matter. You can look up exactly what the FDA reviewed, when it was approved, and even see the original application. This isn’t just for doctors—it’s for anyone who wants to know what’s really in their medicine. And if something goes wrong? You can check the FDA Safety Communications Archive for past warnings on your drug, from EpiPens to antipsychotics.
What you’ll find below isn’t a list of every FDA approved drug. It’s a practical guide to understanding how they work, how they’re priced, how they compare, and how to use them safely. You’ll read about how insurance pushes generics to save money—and why that doesn’t always mean lower out-of-pocket costs. You’ll learn how to spot dangerous interactions between common meds. You’ll see how real people report side effects that help improve drug safety for everyone. And you’ll get clear comparisons between similar drugs, from Zofran to lisinopril to sildenafil, so you know what’s actually different and what’s just marketing.
Orange Book Database: FDA's Approved Drug Products and Therapeutic Equivalence Ratings
Posted by Ellison Greystone on Nov, 22 2025
The Orange Book database is the FDA's official list of approved drugs with therapeutic equivalence ratings, patent info, and exclusivity data-critical for generic drug approval and substitution.
Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence Ratings
Posted by Ellison Greystone on Nov, 22 2025
The Orange Book database is the FDA's official list of approved drugs with therapeutic equivalence ratings, patent info, and exclusivity periods. It enables generic drug competition and saves billions in healthcare costs.