Drugs@FDA is FDA's database of approved drugs and the paperwork behind them. Here is how to search Drugs@FDA and its monthly approval reports, what it leaves out, and how ClinicaLister links every approval to its substance, its clinical trials and its patents.
Drugs@FDA covers drug products approved for human use in the United States, including the therapeutic biologics regulated by FDA's drug center. It lists brand-name and generic products, prescription and over-the-counter, current and discontinued, with tentative approvals for generics that are waiting on patents or exclusivity.
Each entry is organised by application — an NDA for a new drug, an ANDA for a generic, a BLA for a biologic — with its products (strength, dosage form, route, marketing status) and the history of submissions and actions. For brand-name prescription drugs it usually links to the approval letter, the current label and FDA's review documents.
Products regulated by FDA's biologics center — vaccines, blood products, and cell and gene therapies — are not in Drugs@FDA.
Drugs@FDA has a search box, an alphabetical browse and a set of monthly approval reports. The same data is available as daily data files and through openFDA.
Type at least three characters of a drug name, an active ingredient or an application number (for example 217806, the Zepbound NDA) into the search box, then pick the product from the results.
An application page lists its products with strength, dosage form, marketing status and therapeutic equivalence code, followed by every approval action. Open the approval date's row for the letter, label and review documents where FDA has posted them.
Under Drug Approval Reports by Month, choose a report — all approvals, original NDA and BLA approvals, original generic approvals, supplemental approvals or tentative generic approvals — then pick the month and year.
FDA publishes the full database as a zipped set of 12 text tables (applications, products, submissions, marketing status and more), refreshed each weekday morning.
The openFDA endpoint https://api.fda.gov/drug/drugsfda.json returns the same applications as JSON — for example search=sponsor_name:"ELI LILLY AND CO", which must match the sponsor name exactly — with up to 1,000 records per call.
85% of ClinicaLister's Drugs@FDA records carry a UNII substance code, so brand, generic and combination products roll up to the same molecule instead of living under separate names.
Each molecule's approvals sit beside its clinical trials — through 401,000+ verified molecule–trial links — so you can see what is approved and what is still in development in one place.
The same view shows the drug's label from DailyMed, its NDC listings, its Orange Book patents and exclusivity where FDA lists them, its FAERS serious-report summary, shortages and EMA authorisation.
Changes to Drugs@FDA records for molecules linked to the trials you follow appear in the app's Monitoring view, so a new approval or status change for a competitor shows up without re-running a report.
The free Clinical Trials Pulse lists each week's FDA approvals with sponsors and dates, next to new trials and shortages.
29,800+
Drugs@FDA product records
85%
anchored to a UNII substance
Daily
sync from FDA's openFDA data
401,000+
verified molecule–trial links
ClinicaLister holds the full Drugs@FDA dataset from openFDA, synced daily. Counts measured on the ClinicaLister platform database, August–September 2026.
Drugs@FDA is FDA's public database of drug products approved for human use in the U.S. — brand and generic, prescription and over-the-counter — with approval history and, for many products, approval letters, labels and reviews.
In Drugs@FDA, open Drug Approval Reports by Month, choose the report type (for example original NDA and BLA approvals) and pick the month and year.
It includes therapeutic biologics regulated by FDA's drug center. Vaccines, blood products, and cell and gene therapies are regulated by the biologics center and are not included.
Drugs@FDA is the record of each approved application and its documents. The Orange Book lists approved products with their therapeutic equivalence codes and the patents and exclusivity periods that apply to them. Both come from FDA's drug center and share application numbers.
FDA refreshes the Drugs@FDA data files each weekday morning. ClinicaLister syncs the dataset daily.
See every approval next to the drug's trials
Built for the Regulatory Affairs Specialist. See it in the product: Drug & Device Details. All data sources