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U.S. Department of Health and Human Services

Drugs

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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
•  Labels
•  Consumer Info sheets
•  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).
    • Consumer Information Sheet (available for drugs approved since 1998)
    • Patient Information Sheets
    • 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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