Drugs@FDA
  Frequently Asked Questions

1. What is the purpose of Drugs@FDA, and what are its main uses? 

Drugs@FDA is a Web site where you can search for official information about FDA approved brand name and generic drugs.

The main uses of Drugs@FDA are:

• Finding labels for approved drug products.
• Finding generic drug products for a brand name drug product.
• Finding therapeutically equivalent drug products for a brand name or generic drug product.
• Finding consumer information for drugs approved from 1998 on.
• Finding all drugs with a specific active ingredient.
• Viewing the approval history of a drug.

2. What Drug Products are in Drugs@FDA?

Drugs@FDA contains prescription and over-the-counter human drugs currently approved for sale in the United States.  Drugs@FDA also contains discontinued drugs.

Drugs@FDA contains the following biological therapeutic products:

• Monoclonal antibodies for in-vivo use
• Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
• Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
• Other non-vaccine therapeutic immunotherapies

Not all biologic therapeutic products are in Drugs@FDA.

Drugs@FDA contains most of the drug products approved since 1939.  The majority of labels, approval letters, reviews, and other information are available for drug products approved from 1998 to the present.

3. What Drug Products are not in Drugs@FDA?

Drugs@FDA does not include:

• Dietary supplements. 
• Drugs for animals.  FDA's Center for Veterinary Medicine is responsible for the agency's oversight of these products. 
• Drugs withdrawn for reasons of safety or effectiveness.
• Over-the-counter products that are approved for marketing through a process other than submitting a New Drug Application. 
• Prescription drugs sold in countries other than the United States. 
• Prescription drugs sold (illegally) in the United States without FDA approval.
• Drugs that are under review at FDA for which no action regarding approval has occurred. 
• Biological products including bacterial and viral vaccines; human blood products; certain blood products produced by biotechnology; and gene therapy. FDA's Center for Biologics Evaluation and Research is responsible for the agency's oversight of these products. 

4. Why doesn't Drugs@FDA include dietary supplements?

• Dietary supplements do not require FDA approval to be sold in the United States.  FDA's Center for Food Safety and Applied Nutrition is responsible for the agency's oversight of these products.

5.  How can I find out if a generic drug is available for a brand name drug?

• Find the "Drug Details" page for your drug by following Instructions to Finding Health Information.
• If a generic drug is available, you will see the link "Therapeutic Equivalence" in the middle of the Drug Details page. Click on this link to see the generic and other therapeutically equivalent drug products for your drug.
• Be sure to read the definitions for Generic Drug and Therapeutic Equivalents.

6. What information is available for each drug product in Drugs@FDA?

Search results for all drug products include:

• drug name (brand name or generic name)
• active ingredient
• dosage form or route of administration
• strength
• marketing status (prescription, over-the-counter, or discontinued)
• company that sponsored an application for approval
• FDA action date
• Supplement type (type of regulatory action)

Many, but not all drug products have links to:

• current FDA approved labels
• older labels
• approval letters
• reviews (scientific analyses of new drug applications that provide the basis for approval)

7. How can I search Drugs@FDA?

You can search by:

• drug name 
• generic name
• active ingredient
• drug name and FDA Action Date range
• application number (NDA, ANDA, BLA)
• action dates of approvals and supplements in one, two, or three month blocks

Detailed instructions for searching Drugs@FDA are available.

8. How do searches work in Drugs@FDA?

The drugs that are listed on the "Search Results" page are not always related in terms of their chemical makeup or the conditions they treat, and are not necessarily substitutable.  They appear together because their drug names or active ingredient names contain the words or parts of words you entered in the search box.  The text you searched for appears in bold letters in the search results.

Even if drug products have the same active ingredient, dosage form, and strength, it might not be safe to use one in place of the other.  You should always consult a health care professional to determine if one drug can be safely substituted for another, that is, if they are therapeutically equivalent.

How searches work:

• When you enter a string of characters to search Drugs@FDA, you are searching for that string of characters in the exact order you typed them, anywhere in a drug name or an active ingredient name.
• Example:
  If you enter "proz" you will retrieve drug products that have that four-letter string somewhere in their drug names or active ingredient names:
  • CEFPROZIL   [from the "Active Ingredient" column]
  • OXAPROZIN POTASSIUM   [from the "Active Ingredient" column]
  • PROZAC   [from the "Drug Name" column]
  • PROZAC WEEKLY   [from the "Drug Name" column]
    
    
• Tip:  Enter as much of the name as you know to focus your results.  For example, if you know you want to retrieve the records for Prozac, enter the entire word.
  
  
• If you enter two or more words separated by a space, Drugs@FDA will look for records containing both of the words, whether they occur together or apart, in either a drug name or an active ingredient name.
• Example:
  If you enter "claritin pseudoephedrine" you will retrieve drug products that have either one of those words in either their drug names or active ingredient names:
  • CLARITIN-D  (LORATADINE; PSEUDOEPHEDRINE SULFATE)
  • CLARITIN-D 24 HOUR  (LORATADINE; PSEUDOEPHEDRINE SULFATE)

9. How often do you update Drugs@FDA?

We add new drug approvals every day, sometimes several times throughout the day.

10. Where does the information in Drugs@FDA come from? 

The information in Drugs@FDA comes from: 

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) 

• Center-wide Oracle-based Management Information System (COMIS).  COMIS is used by FDA staff to track information about the receipt and review status of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs).

11. How can I get further assistance?

• For general drug information:
  • Call 301-827-4573 or 888-INFO-FDA (1-888-463-6332)
  • E-mail your questions to druginfo@cder.fda.gov
• For technical questions about this site, please use our Drugs@FDA Comments and Feedback form.

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