How to Search FDA’s Drugs@FDA Database for Official Drug Information

Want to find out when a drug was approved by the FDA, who made it, or what the official prescribing information says? You don’t need to call the agency or dig through PDFs. The Drugs@FDA database is free, public, and built for exactly this. Whether you’re a pharmacist checking a patient’s medication, a researcher reviewing approval history, or just someone trying to understand what’s in your prescription, this tool gives you direct access to official FDA records-no login, no fee, no hassle.

What Is Drugs@FDA and Why Does It Matter?

Drugs@FDA isn’t just a list of approved drugs. It’s the FDA’s official archive of regulatory paperwork. For every drug approved since 1998, you can see the exact documents the FDA reviewed before giving approval-medical evaluations, pharmacology reports, even emails between the agency and the drug company. For older drugs, you’ll get basic approval info and labels. This level of transparency is rare in global health systems.

It’s not the only FDA drug database. The Orange Book tells you which generics are therapeutically equivalent. FDALabel lets you search inside the text of prescribing information for things like "black box warnings" or "side effects." The Purple Book covers biologics like insulin or monoclonal antibodies. But Drugs@FDA is the starting point for almost every drug inquiry because it ties everything together: approval date, who applied, what’s in the drug, and what the FDA said about it.

How to Search Drugs@FDA: The Two Main Ways

There are two ways to search Drugs@FDA-and only one of them gives you full results.

1. Use the Homepage Search Box (Recommended)

This is the fastest, most reliable method. Go to www.accessdata.fda.gov/scripts/cder/daf/ (the official Drugs@FDA site). In the big search box at the top, type:

• A brand name like Zoloft
• A generic name like sertraline
• An active ingredient like lisinopril
• An application number like NDA 020615

Hit Enter. Within seconds, you’ll see a list of matching drugs. Each result shows:

• Brand name and generic name
• Active ingredient(s)
• Applicant (company)
• Approval date
• Therapeutic equivalence code (if applicable)

Click on any drug to open its full record. Here you’ll find downloadable PDFs of:

• Full prescribing information (the official label)
• Patient Medication Guides
• Approval letters from the FDA
• Review summaries by FDA medical officers
• Correspondence between FDA and the manufacturer

This is the gold standard for verifying a drug’s history. If you need to know when a drug first hit the market, or if a generic version was approved, this is where you’ll find it.

2. Use the A-Z Index (Use With Caution)

At the bottom of the homepage, there’s an A-Z index labeled "Drug Name." It looks helpful-but it’s misleading.

Searching for lisinopril in the A-Z index will only return products where lisinopril is the only active ingredient. It won’t show:

• Brand names like Prinivil or Zestril
• Combination drugs like Zestoretic (lisinopril + hydrochlorothiazide)
• Any drug with multiple ingredients

That’s a huge gap. If you rely on the A-Z index alone, you’ll miss most of the drugs you’re looking for. The FDA’s own training materials warn users about this limitation. Always use the main search box first.

What You Won’t Find in Drugs@FDA

Drugs@FDA is powerful-but it’s not perfect. Here’s what’s missing:

• Animal drugs-those are in a separate database called Animal Drugs@FDA.
• Over-the-counter (OTC) monograph drugs-those approved under general rules, not individual applications.
• Detailed patent information-for that, use the Orange Book.
• Section-by-section label searches-like finding all mentions of "dizziness" in prescribing info. Use FDALabel for that.
• Real-time pricing or availability-this is regulatory data, not a pharmacy inventory.

If you’re trying to figure out if a generic version is interchangeable with a brand, check the Orange Book. If you need to search for all drugs with a specific side effect in the label, use FDALabel. Drugs@FDA gives you the approval story. Other tools give you the fine print.

Real-World Use Cases

Here’s how people actually use Drugs@FDA:

• Pharmacists verify if a drug was approved before dispensing an unusual prescription. One pharmacist told the FDA, "I used to call them. Now I just search Drugs@FDA. It saves me 15 minutes every time."
• Doctors check approval dates when a patient reports a new medication. If a drug was approved last year, they know it has less long-term data.
• Researchers track how long it took a drug to get approved after submission. Some drugs took 3 years; others took 8. Drugs@FDA shows the timeline.
• Patients look up their medication to read the official label instead of relying on vague internet summaries. They see exactly what the FDA reviewed.
• Students and educators use it to teach drug development, regulatory science, and evidence-based medicine.

One common scenario: A patient asks, "Is this generic version as good as the brand?" You open Drugs@FDA, find both the brand and generic, check their approval dates, and see if they have the same therapeutic equivalence code. Then you check the Orange Book to confirm they’re rated AB-meaning they’re considered interchangeable. That’s the full picture.

Pro Tips for Better Searches

• Use the generic name-it’s more consistent than brand names, which change over time.
• Try partial names-searching for "lisin" will still return lisinopril.
• For combination drugs, search by one active ingredient. If you’re looking for Zestoretic, search for "lisinopril"-it will appear in the results.
• Copy and paste application numbers if you have them. NDA 020615 is faster than typing "Zoloft".
• Bookmark the site-it’s the most reliable source for official FDA drug data.

What’s Next? Other FDA Resources to Know

Once you’re comfortable with Drugs@FDA, expand your toolkit:

• FDALabel - Search inside the full text of drug labels for specific symptoms, warnings, or dosing info.
• Orange Book - Find therapeutic equivalence codes and patent/exclusivity data for generics.
• Purple Book - For biologics: insulin, vaccines, monoclonal antibodies.
• Animal Drugs@FDA - For veterinary medications.

These tools work together. Drugs@FDA tells you if and when a drug was approved. The Orange Book tells you if a generic is interchangeable. FDALabel tells you what the risks and instructions are. Mastering all four gives you complete regulatory insight.

Final Thoughts

Drugs@FDA is not flashy. It doesn’t have fancy filters or interactive charts. But it’s the most trusted source for official FDA drug approval records. It’s been used by thousands of healthcare professionals every day since the late 1990s. And it’s free.

If you need to know the truth about a drug’s approval history, this is where you go. No third-party blogs. No pharmacy websites. No marketing pages. Just the FDA’s own documents. That’s power.

Start with the search box. Ignore the A-Z index. Save the results. Bookmark the site. And next time someone asks you about a drug’s approval date or label, you’ll know exactly where to look.

If you’re a healthcare provider, researcher, or just someone who wants to understand what’s in your medicine, Drugs@FDA is the most direct path to official FDA data. No intermediaries. No guesswork. Just the facts.