Step‑by‑Step Guide to Searching the FDA Drugs@FDA Database

When you need official drug details, Drugs@FDA is the U.S. Food and Drug Administration’s online database that houses approval letters, labeling, and review documents for every FDA‑approved human drug since 1939. The portal is free, updates daily, and works in any modern browser, so you don’t have to file a Freedom of Information Act request just to see a label or approval date.

Key Takeaways

• Three core search modes: drug name (brand or generic), active ingredient, and application number (NDA, ANDA, BLA).
• Use the homepage search box for quick look‑ups; the A‑Z Index is better for systematic browsing.
• Combine results with FDALabel, the Orange Book, or the Purple Book when you need detailed labeling sections or patent data.
• Watch out for brand‑name gaps in the A‑Z “Drug Name” search - it only returns exact matches.
• Keep a checklist handy to verify you’ve captured the approval letter, label, and any patient‑medication guide.

What the Drugs@FDA Database Actually Contains

The site stores roughly 20,000 approved products. For each entry you’ll find a set of downloadable PDFs, including the original approval letter, the full prescribing label, any patient medication guide, and the “action package” that documents the FDA’s review notes. Products approved after 1998 have the most complete record set; older approvals may lack some supplementary files.

Beyond the drug‑specific files the database also shows the regulatory pathway used:

• New Drug Application (NDA) - the primary route for brand‑new molecular entities.
• Abbreviated New Drug Application (ANDA) - used for generic equivalents.
• Biologics License Application (BLA) - for biologic products such as monoclonal antibodies.

Choosing the Right Search Method

Before you type anything, decide what you actually need. Are you looking for a specific brand’s label? The active ingredient across multiple brands? Or the regulatory paperwork tied to an application number? Your answer determines which of the three search pathways will be most efficient.

Step‑by‑Step Search Walkthrough

1. Identify the information you need. Is it the approval date, the full label, or the patient guide?
2. Select the appropriate search mode. For a brand name like "Lipitor," choose Drug Name. For "atorvastatin" across all brands, pick Active Ingredient. For an NDA number such as "022254," go with Application Number.
3. Enter your term in the homepage search box. The box sits at the top of the Drugs@FDA landing page. Hit Enter.
4. Review the results list. Each line shows the product name, its application type (NDA, ANDA, BLA), and the submission date. Click the product that matches your target.
5. Navigate the product page. On the left you’ll see tabs like "Label," "Approval History," and "Patient Medication Guide." Download the PDF you need.
6. Verify the document version. The FDA updates labels when safety information changes. Look for the most recent date in the file name.
7. Document the source. Copy the URL and note the accession number; it’s useful for citations or compliance audits.

Advanced Tips & Common Pitfalls

Tip 1 - Use the A‑Z Index for batch browsing. If you need every product that contains "lisinopril," click the A‑Z Index link, choose "Active Ingredient," then scroll to "L." This method avoids the 30‑second limit of the homepage box for large result sets.

Tip 2 - Combine searches. Start with an ingredient search to get a list of brands, then copy a brand name into the home box to fetch its full label.

Pitfall - Missing brand names in the A‑Z "Drug Name" search. The index only returns exact matches, so searching for "LISINOPRIL" will not pull "PRINIVIL" or "ZESTRIL." When you suspect a brand name, always run a separate brand‑name query.

Pitfall - Older approvals. Drugs approved before 1998 often lack digital patient guides. If you can’t find a PDF, check the FDA’s Freedom of Information archives or the historical “Drug Product Labeling” collection.

Linking Drugs@FDA with Other FDA Resources

If you need deeper labeling sections (e.g., boxed warnings), head over to FDALabel. It lets you search the label text itself. For therapeutic equivalence, the Orange Book shows which generics are considered bioequivalent. Biologic products have a dedicated Purple Book. All three sources include direct links back to the corresponding Drugs@FDA record, making cross‑referencing painless.

Quick Checklist Before You Close the Session

• Did you choose the right search mode (name, ingredient, application number)?
• Have you downloaded the approval letter, label, and any patient guide?
• Is the document the latest version (check the revision date)?
• Did you note the URL and the FDA accession number for future reference?
• If you need more detail, have you checked FDALabel, Orange Book, or Purple Book?

Frequently Asked Questions