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

When you need to know if a drug is truly approved by the U.S. Food and Drug Administration - not just listed on a website or in a pharmacy catalog - there’s one place that matters most: Drugs@FDA. It’s not a marketing site. It’s not a blog. It’s the official source. Every approval letter, every label update, every review document from the FDA’s own scientists is stored here. And it’s free. No login. No subscription. Just direct access to the regulatory truth.

What Exactly Is Drugs@FDA?

Drugs@FDA is the FDA’s public database for human drug products approved since 1939. It holds records for about 20,000 drugs, including brand-name pills, generics, and biologics. For drugs approved after 1998, you get the full package: the prescribing information (what doctors call the “label”), patient medication guides, approval letters, and even internal FDA reviews written by medical officers. For older drugs, you’ll still find the approval date and basic details - just not all the documents.

It’s not the same as FDALabel, which lets you search within the text of drug labels for phrases like “black box warning” or “side effects.” Drugs@FDA gives you the full context - why the drug was approved, what studies were done, and what the FDA’s own experts said. It’s also different from the Orange Book (which tracks generic drug equivalence and patents) and the Purple Book (which is only for biologics like insulin or monoclonal antibodies). If you want to know the full regulatory story behind a drug, Drugs@FDA is where you start.

How to Search by Drug Name

The easiest way to find a drug is by typing its name into the big search box on the homepage. You can use either the brand name - like Viagra - or the generic name - like sildenafil. The system understands both. Type in “lisinopril” and you’ll get all drugs containing that ingredient, including Zestril, Prinivil, and combination pills like Zestoretic.

But here’s the catch: if you use the A-Z index instead of the search box, you won’t get the same results. The A-Z index only lists exact matches for the generic name. So if you search for “LISINOPRIL” in the A-Z list, you won’t see Zestril or Prinivil. That’s a common mistake. Always use the main search box unless you’re specifically looking for the exact generic name and know what you’re doing.

Searching by Active Ingredient

Let’s say you’re trying to find all drugs that contain metformin. Type “metformin” into the search box. The results will show you every product - brand and generic - that includes it. You’ll see Glucophage, Fortamet, Riomet, and combo drugs like Janumet (metformin + sitagliptin). Each result links to a detailed page with the drug’s approval history, labeling, and documents.

This is especially useful if you’re comparing generics or checking whether a new formulation has been approved. For example, if your pharmacist says a new extended-release version of metformin is available, you can confirm it’s FDA-approved by searching the ingredient and checking the approval date.

Using Application Numbers (NDA, ANDA, BLA)

If you’re a researcher, pharmacist, or industry professional, you might have an application number. These are the official FDA IDs assigned to each drug submission:

• NDA - New Drug Application (brand-name drugs)
• ANDA - Abbreviated New Drug Application (generic drugs)
• BLA - Biologics License Application (biologics like vaccines or monoclonal antibodies)

Just type the number - like NDA 020472 - into the search box. You’ll jump straight to the full approval file. This is how FDA staff and pharmaceutical companies verify approvals quickly. No guessing. No filtering. Just the exact record.

What You’ll See in the Results

Click on a drug in the search results, and you land on a page with six main sections:

1. Product Information - Brand name, generic name, dosage form, strength, manufacturer.
2. Approval History - The date the drug was first approved, any later approvals for new strengths or forms.
3. Therapeutic Equivalence - For generics, this tells you if the FDA considers it interchangeable with the brand (rated “A” or “B”).
4. Labeling - The full prescribing information (PDF). This is what your doctor reads.
5. Review Documents - Internal FDA reports from medical, pharmacology, and chemistry reviewers. These explain why the drug was approved - or sometimes why it was delayed.
6. Application Documents - Letters between the FDA and the company, including requests for additional data.

For drugs approved after 1998, you’ll see all of these. For older drugs, some sections might be blank. That doesn’t mean the drug isn’t approved - it just means the documents weren’t digitized yet.

Common Mistakes and How to Avoid Them

People get tripped up in three main ways:

• Using the A-Z index instead of the search box - As mentioned, the A-Z index only finds exact generic names. Don’t use it unless you’re sure you want only the base ingredient.
• Searching for combination drugs by one ingredient - If you’re looking for Zestoretic (lisinopril + hydrochlorothiazide), search for “Zestoretic” or “hydrochlorothiazide,” not just “lisinopril.” The system won’t automatically link combination products unless you search the full name or both ingredients.
• Assuming all drugs have full documents - Drugs approved before 1998 may only show approval dates and basic info. Don’t assume missing documents mean the drug isn’t approved. It’s just older.

Also, remember: Drugs@FDA only covers human drugs. Animal drugs are in a separate database called Animal Drugs@FDA. If you’re looking for a pet medication, you’re in the wrong place.

When to Use Other FDA Databases

Drugs@FDA is powerful, but it’s not the only tool. Here’s when to use others:

• FDALabel - If you need to search for specific phrases like “contraindicated in pregnancy” or “risk of QT prolongation” across all labels, use FDALabel. It’s built for deep text searches.
• Orange Book - If you’re a pharmacist checking whether a generic is therapeutically equivalent to the brand, or if there are patent exclusivity issues, go here.
• Purple Book - For biologics like Humira, Enbrel, or insulin analogs, use the Purple Book. Drugs@FDA includes them, but the Purple Book gives you detailed biosimilar information.

Most people start with Drugs@FDA. If they need more detail, they move to one of the others. Think of Drugs@FDA as your first stop - the overview. The others are for deeper dives.

Why This Matters in Real Life

Imagine you’re a nurse helping a patient who says their new prescription isn’t working like the old one. You pull up Drugs@FDA, search the generic name, and see that the new version was approved just last month. The label says it’s an extended-release formulation - that’s why the timing’s different. No guesswork. No calling the FDA. Just the facts.

Or you’re a student writing a paper on how long it takes for a new diabetes drug to reach the market. You find the original NDA, track the approval date, and pull the FDA’s review comments - all from one site.

Even patients use it. If you’re curious why your medication has a black box warning, you can read the FDA’s own explanation - not a blog post or a drug company’s website.

Final Tips for Getting the Most Out of Drugs@FDA

• Always use the main search box - not the A-Z index - unless you’re searching for the exact generic name.
• Save the results page. You can bookmark it or print the PDFs of labels and reviews.
• Check the approval date. A drug might be approved, but if it’s new, side effects might still be emerging.
• If you can’t find a drug, try spelling variations. Sometimes the brand name is different from what you expect (e.g., “Prozac” vs. “fluoxetine”).
• Use the “Application Number” if you have it. It’s the fastest way to get the exact record.

The FDA updates Drugs@FDA every day. New approvals, label changes, recalls - they all show up here first. If you rely on drug information for your job, your family, or your health, this is the only source you need to trust.