- 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 a brand name 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?
Drugs@FDA allows you to search for official information about FDA
approved brand name and generic drugs and therapeutic
The main uses of
- finding labels for approved drug
- 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
- viewing the approval history of a
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
- 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
- animal drugs, which are regulated by the Center for Veterinary
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
- 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 (brand name or generic
- active ingredient
- dosage form or route of
- 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
- 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
- original and supplemental approvals by month
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
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
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
11. How does Drugs@FDA
compare with the Orange Book?
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
- 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
12. What do the Chemical Type and Review Classification codes stand for?
NDA Chemical Types
New molecular entity (NME)
New ester, new salt, or other noncovalent derivative
Drug already marketed, but without an approved NDA
OTC (over-the-counter) switch
Priority review drug: A drug that appears to represent an advance
over available therapy
Standard review drug: A drug that appears to have therapeutic
qualities similar to those of an already marketed drug
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.
14. How can I get further assistance?