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