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  1. Drug Approvals and Databases

Drugs@FDA Instructions: Quick Search Instructions

Quick Search
 Start here to learn the basics of searching Drugs@FDA.
Health Information
 Therapeutic equivalents
 Generics for a brand name drug
  Medication Guides
 Patient Package Inserts
 More Information from FDA
Regulatory Information
 Labels   Letters  Reviews
 Approval History
 Supplement Types
 Generics for a brand name drug
 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

Quick Search 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 lists summary information about the drug and provides links to consumer and regulatory information, the application history, therapeutic equivalents, and labels.

To find information on a drug product:  

  • 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, or by company, and click on the drug name in the first column. This will take you to the Drug Details page.  (If there is only one application that matches your search, you will not see the Search Results and Overview page.)
  • The Drug Details page lists the following information:
    • Drug Name
    • Application Number
    • Active Ingredient(s)
    • Chemical Type (for NDAs)
    • Review Classification
    • Original Approval Date
  • 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 Equivalence.
    • Other OTC Drugs with the Same Active Ingredient (if available for an over-the-counter-drug).
    • Label Information
    • Medication Guide (contains information for patients on how to safely use a drug product.)
    • Approval History and Related Documents (Reviews, Approval Letters, Approval Packages, Current and Archived Labels)
    • Other Important Information from FDA (may include FDA Alerts, Public Health Advisories, and questions and answers)

Note: Not all information is available for all drug products.


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