Everything you always wanted to know about approved medicines (but didn't know where to look)
Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?
By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products. The database includes most of the drug products approved since 1939 and has drug labels, patient information, approval letters, and other information for most drug products approved since 1998.
You can use Drugs@FDA to find:
- Labels for drug products
- If there are generic drug products for an innovator (“brand name”) drug product
- Therapeutically equivalent drug products. Drug products that are therapeutically equivalent control a symptom or condition in the exact same way as another drug product.
- Consumer information for drugs
- All drugs with a specific active ingredient
- The approval history of a drugs, including approval letters and review documents
If you search for a drug product, the results will include its name; active ingredient; dosage form, such as tablet, capsule or injection; route of administration, such as oral, nasal, or intramuscular; strength; and whether it’s a prescription, over-the-counter or discontinued product, or tentatively approved.
Click and Search
The Drugs@FDA database is organized using the FDA application number -- a unique tracking number FDA assigns to each new drug application. Since different dosage forms, routes of administration, and strengths of a drug can have different application numbers, you may get multiple results when searching using the drug’s name.
Most people will not have an application number to begin a search, so it will help to know the dosage form, route and drug strength.
To find information about a drug product, enter the drug’s name or active ingredient in the search box. If you don't know the whole name, type in as much as you know but at least three characters. You can also click on the first letter of the drug name in the browse box and get a list of all drugs starting with that letter.
If there is more than one application number for the drug name, you will go to an overview page, and one more click gives you all the available details about the drug. There are links to medication guides, plans to help reduce risks associated with the use of a drug – also known as a risk evaluation mitigation strategy, a drug’s approval history, drug safety advisories and other information.
Dietary supplements, animal drugs, and drugs sold outside the United States not approved by FDA are not tracked in Drugs@FDA.
- Drugs@FDA Instructions: Quick Search Instructions
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations