Drugs@FDA Frequently Asked Questions
- What is the purpose of Drugs@FDA, and what are its main uses?
- What drug products are in Drugs@FDA?
- What drug products are not in Drugs@FDA?
- Why doesn't Drugs@FDA include dietary supplements?
- How can I find out if a generic drug is available for an innovator drug?
- What information is available for each drug product in Drugs@FDA?
- How can I search Drugs@FDA?
- How do searches work in Drugs@FDA?
- How often do you update Drugs@FDA?
- Where does the information in Drugs@FDA come from?
- How does Drugs@FDA compare with the Orange Book?
- What do the Chemical Type and Review Classification codes stand for?
- Can I get a copy of the Drugs@FDA database?
- How can I get further assistance?
1. What is the purpose of Drugs@FDA, and what are its main uses?
The main uses of Drugs@FDA are:
- finding labels for approved drug products
- finding generic drug products for an innovator drug product
- finding therapeutically equivalent drug products for an innovator 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 and therapeutic biologicals currently approved for sale in the United States. Drugs@FDA includes discontinued drugs and "Chemical Type 6" approvals.
Drugs@FDA contains the following therapeutic biological products:
- monoclonal antibodies
- 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 therapeutic biological 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:
- over-the-counter (OTC) products approved for marketing through a process other than submission of a New Drug Application or Biologic License Application
- drugs sold outside the United States that are not approved for marketing in the U.S.
- drugs not approved by the FDA
- drugs under review at FDA for which no action (approved or not approved) has occurred yet
- dietary supplements, which do not require FDA approval to be sold in the United States
- biological products regulated by the Center for Biologics Evaluation and Research
- animal drugs, which are regulated by the Center for Veterinary Medicine
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.
- 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 Equivalents" 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?
The search results for all drug products include:
- drug name
- active ingredient
- dosage form or route of administration
- marketing status (prescription, over-the-counter, or discontinued)
- company that sponsored an application for approval
- FDA action date
- approval type (type of supplement type or other regulatory action)
Results for New Molecular Entities include:
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)
- information for patients
7. How can I search Drugs@FDA?
You can search by:
- drug 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
- original and supplemental approvals by month
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.
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.
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)
- You cannot combine and Application Number searches with Drug Name or Active Ingredient searches. This search will not work: fluoxetine 018936.
9. How often do you update Drugs@FDA?
We make changes to the database every day, sometimes several times throughout the day. When we are notified that a supplement has been approved, we wait 24 hours to add the information, with the exception of special approvals.
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).
Drugs@FDA overlaps with the Orange Book in many aspects of content and retrieval capabilities, but it is not intended to replace the Orange Book. You can read about the origin and purpose of the Orange Book in the Preface to the Annual Edition.
- All of the drugs listed in the Orange Book appear in Drugs@FDA.
- Drugs@FDA includes information not included in the Orange Book:
- The Orange Book includes information not included in Drugs@FDA:
- Patent and exclusivity information
- The Orange Book is updated daily for new generic drug approvals and patent information and monthly for other information.
- We update Drugs@FDA daily with information on new approvals and supplemental approvals, links to documents, and the latest Orange Book data.
- Drugs@FDA provides features not available in the Orange Book, including:
- tables of therapeutic equivalents grouped by product.
- tables, grouped by product, showing over-the-counter drugs containing the same active ingredient
- drug approval histories
- links to documents and web pages related to the approval history, drug safety, and patient information
- date-range searches
- drug approval reports by month
- The Orange Book provides features not available in Drugs@FDA , including:
- search by applicant
- search by patent
- search by type: prescription (Rx), over-the-counter (OTC), and discontinued
|1||New molecular entity (NME)|
|2||New active ingredient (new salt, new noncovalent derivative, new ester)|
|3||New dosage form|
|5||New formulation or new manufacturer|
|6||New indication [no longer used]|
|7||Drug already marketed without an approved NDA|
|8||OTC (over-the-counter) switch|
|9||New indication submitted as distinct NDA, consolidated with original NDA after approval|
|10||New indication submitted as distinct NDA - not consolidated|
|P||Priority review drug: A drug that appears to represent an advance over available therapy|
|S||Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug|
|O||Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans|
13. Can I get a copy of the Drugs@FDA database?
Yes. Please see the page "Drugs@FDA Data Files" for information about the database tables and a link to the compressed file for downloading. The file does not include the scripts (programming) we use to produce the online version of Drugs@FDA. We are providing this technical information for users who are familiar with working with databases or spreadsheets.
- For general drug information:
- Call 301-827-4573 or 888-INFO-FDA (1-888-463-6332)
- E-mail your questions to firstname.lastname@example.org
- For technical questions about this site, please use our Drugs@FDA Comments and Feedback form.