More Instructions: Quick Search Regulatory Information Advanced Search
First, search for a drug and choose an FDA application:
- On the main Search page, enter the drug name or active ingredient in the search box. If you don't know the whole
name, type in as much as you know (at least three characters). You can also search by application number; however, do not enter both the number and the name. You may also click on the first letter of
the drug name in the Browse Box.
- On the Search Results page, click on your drug name.
- On the Overview page, find your drug product by its dosage
form/route and strength, and click on the drug name in the Drug Name and FDA Application
Number column.
This
will take you to the Drug Details page for an individual
application. (If there is only one application that matches your search, you will not see the Search Results or Overview page.)
On the Drug Details page, links appear and are live ONLY if the information is
available.
Click on the links on the Drug Detail page for the following
health-related information:
NOTE: While many
people commonly use the phrase "generic for the brand name
drug," Drugs@FDA uses a more precise official term for the drug(s)
a pharmacist may substitute for another drug: therapeutic
equivalent. |
1. Therapeutic Equivalents
This link appears for prescription drugs only. (Over-the-counter drugs will have a link called "Other
OTC Drugs with the same Active Ingredient"). This link will be
active only if generics or other
therapeutic equivalents are available for your prescription drug product. Note: Please read definitions for Generic Drug and Therapeutic Equivalence.
- Click on the Therapeutic Equivalents link to go to
the Therapeutic Equivalents page. This page will show you generic
drug products or other brand name products that are available as
therapeutic equivalents for another prescription drug
product.
Note: If your drug
is an over-the-counter drug product, the link will go to a page called
"Over-the-Counter
Drugs with the Same Active Ingredient." The products listed on
that page are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
- Products appear on the Therapeutic
Equivalents page in tables by product, distinguished by dosage strength. Scroll through the tables
until you find the table listing the products
with the same dosage strength and form/route of
administration as the drug you want to substitute. Drug
products in each table are therapeutically equivalent
to your drug product.
2. Label Information
This link will take you to the most current label that FDA has in
electronic format.
- If Drugs@FDA does not have the latest approved label, you will see a
link to the latest approved label that we do have.
- There will be no link if FDA does not have a label for the drug.
- Links to older labels appear in the Approval History section.
What's in a Drug Product Label?
The FDA approved label is the official
description of a drug product which includes indication (what
the drug is used for); who should take it; adverse events (side
effects); instructions for uses in pregnancy, children, and
other populations; and safety information for the patient.
Labels are often found inside drug product packaging. |
- description of the drug
- clinical pharmacology
- Indications (uses for the drug)
- Contraindications (who should not take the
drug)
- warnings
- precautions
- adverse events (side effects)
|
- drug abuse and dependence
- dosage and administration
- use in pregnancy, use in nursing mothers
- use in children and older patients
- how the drug is supplied
- safety Information for the patient
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3. Approval History and
Related Documents
This link will take you to the drug's action
dates, supplement numbers, supplement types, plus links to the approval letters, reviews,
labels, and patient package inserts (if available), and additional
notes.
- FDA Action dates. The action date tells when any FDA
regulatory action, such as an original or supplemental approval, took
place.
- Supplement numbers. A supplement number is associated
with an existing FDA Application number (NDA, ANDA, BLA). Companies are
allowed to make changes to drugs or their labels after they have been
approved. To change a label, market a new dosage or strength of a
drug, or change the way it manufactures a drug, a company must submit
a supplemental new drug application (sNDA). Each sNDA is assigned a
number which is usually, but not always, sequential, starting with
001.
- Supplement Approval types. Companies are allowed to make
changes to drugs or their labels after they have been approved. To
change a label, market a new dosage or strength of a drug, or change
the way it manufactures a drug, a company must submit a supplemental
new drug application (sNDA). The supplement type refers to the kind
of change that was approved by FDA. This includes changes in
manufacturing, patient population, and formulation.
- Labels. (current and older) The FDA approved label is the
official description of a drug product, which includes indication (what
the drug is used for); who should take it; adverse events (side
effects); instructions for uses in pregnant women, children, and other
populations; and safety information for the patient.
- Approval letter. An official communication from FDA to a drug
application's sponsor that allows the commercial
marketing of the product.
- Drug approval reviews. A review is the basis of FDA's
decision to approve an application. It is a comprehensive analysis of
clinical trial data and other information prepared by FDA drug
application reviewers. A review is divided into sections on medical
analysis, chemistry, clinical pharmacology, biopharmaceutics,
pharmacology, statistics, and microbiology.
- Patient Package Insert. A Patient Package Insert (PPI) contains
information for patients on how to safely use a drug
product.
It is part of the FDA-approved labeling.
4. Medication Guide
- Medication Guides contain information for patients on how to safely use a drug
product. They are available for some drugs with special risk management
information. Not all drugs have Medication Guides. A
Medication Guide is part of the FDA-approved labeling.
5. Consumer Information Sheet (available for drugs approved since
1998)
- Pharmacists from the Center for Drug Evaluation's Drug Information
Branch prepare these information sheets based on the drug’s approved
package insert.
6. Patient Package Insert
- A Patient Package Insert (PPI) contains
information for patients on how to safely use a drug
product.
It is part of the FDA-approved labeling.
7. More Information from FDA
- This link will open an FDA Web
page that includes drug approval information, safety information, questions
and answers about the drug, and other information.
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