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 In this section:

                Unapproved Animal Drugs

Unapproved Animal Drugs

                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding Home
          Animal & Veterinary
          Compliance & Enforcement
          Unapproved Animal Drugs
          How can I use the FDA Online Label Repository to tell if a drug is legally marketed?Unapproved Animal Drugs How can I use the FDA Online Label Repository to tell if a drug is legally marketed?
  
  	
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The FDA Online Label Repository includes labels for both human and animal drugs, but does not contain a complete listing of labels. You can search for a drug’s label using several parameters, such as proprietary name (also known as trade name or brand name), active ingredient, or National Drug Code (NDC) number. When the search results come up, look at the far right column with the header, “Marketing Category,” to tell if the drug is legally marketed.

If the “Marketing Category” column says:
			Meaning:
			Then the drug is:NDA
			New Drug Application
			An FDA-approved human drugANDA
			Abbreviated New Drug Application
			An FDA-approved generic human drugBLA
			Biologics License Application
			An FDA-approved human therapeutic biological productNADA**
			New Animal Drug Application
			An FDA-approved animal drugANADA**
			Abbreviated New Animal Drug Application
			An FDA-approved generic animal drugConditional NADA**
			Conditional New Animal Drug Application
			An FDA-conditionally-approved animal drug for use in a minor species or in a major species under special circumstancesLegally Marketed Unapproved New Animal Drugs for Minor Species**
			FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
			A legally marketed unapproved product for use in a non-food-producing minor species or in an early life stage of a food-producing minor speciesUnapproved Drug Other;
			Unapproved Medical Gas; or
			Unapproved Homeopathic
			No application or Index listing
			Not approved by FDA

**Note*: This table doesn’t include all marketing categories. For a list of marketing categories with definitions, see Marketing Category.

**For information about the approval, conditional approval, and indexing of animal drugs, see Three Pathways to Legal Marketing Status.

If the drug is an approved human or animal drug, a conditionally approved animal drug, or an approved human therapeutic biological product, the six-digit application number is listed in the column with the header, “Application Number or Regulatory Citation.” The six-digit Minor species Index File (MIF) number is listed in this column if the drug is an FDA-indexed animal drug. The column is blank for an unapproved drug.

Click on a specific drug listed in the search results to view the label information. An unapproved drug has disclaimer statements at the top of the label, indicating that FDA has not found the drug to be safe and effective and has not approved the product's labeling.

For each drug in the repository, there is a “Marketing Information” box beneath the label which contains the marketing category of the drug. For an approved human or animal drug, conditionally approved animal drug, or approved human therapeutic biological product, this box also contains the application number. The MIF number is listed if the drug is an FDA-indexed animal drug. No application number is listed if the drug is unapproved.

More tips on using the label to tell if a drug is legally marketed for animals.

                                                                                  Content current as of:
      10/16/2023Unapproved Animal Drugs

          
                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding
 
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