Drugs@FDA
Instructions
Quick
Search
•
Start here to learn the basics of
searching Drugs@FDA
|
Health
Information
•
Generics for a brand drug product
• Labels
• Consumer Info
sheets
• Medication Guides
• Patient Package Inserts
|
Regulatory Information
• Labels •
Letters • Reviews
• Approval History
• Supplement Types
• Generics for a brand drug product
• RLD and TE codes
• NDA
and ANDA Numbers
• Company •
Active Ingredient
|
Advanced
Search
•
Drug Products by Action Dates of Approvals and Supplements
•
FDA Application Number
•
Approvals and Supplements
within a date range
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Printable Version of Instructions
FAQ
Glossary
of Terms
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Instructions
How Drugs@FDA is organized:
- The FDA application number (NDA
or
ANDA or
BLA) is the key to finding information on a drug product.
Different dosage forms/routes and strengths of a drug can have different
application numbers, so you will need to know this information to find the
details on a specific drug product.
- The Overview Page gives you information to help you
select a drug application to view.
- The Drug Details page provides
links to consumer and regulatory information.
To find information on a drug product:
- On the main Search page, enter the drug name in the search box, or click on the first letter of
the drug name in the Browse Box. If you don't know the whole
name, type in as much as you know (at least three characters).
- 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, or by company, and click on the drug name in the
first column.
This
will take you to the Drug Details page.
- On the Drug Details page, you may find links to information
such as:
- Therapeutic Equivalents (if available for a prescription
drug). Note: Please read
definitions for Generic Drug and
Therapeutic Equivalents.
- Other OTC Drugs with the Same Active Ingredient (if available
for an over-the-counter-drug).
- Consumer Information Sheet (available for drugs approved since 1998)
- Label Information
- Medication Guide (contains
information for patients' understanding of how to safely use a drug
product)
- Approval History and Related
Documents (Reviews,
Approval Letters, Approval Packages, Current and Archived Labels)
Note: Not all information is available for all drug products.
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