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U.S. Department of Health and Human Services

Animal & Veterinary

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How can I use an online database of drug labels to tell if a drug is FDA-approved?

  • FDA Online Label Repository
  • DailyMed
     

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 (trade 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 approved.
 

If the “Marketing Category” column says: Meaning:  Then the drug is:
NDANew Drug ApplicationAn FDA-approved human drug
ANDAAbbreviated New Drug ApplicationAn FDA-approved generic human drug
BLABiologics License ApplicationAn FDA-approved human therapeutic biologic produc
NADANew Animal Drug ApplicationAn FDA-approved animal drug
ANADAAbbreviated New Animal Drug ApplicationAn FDA-approved generic animal drug
CNADAConditional New Animal Drug ApplicationAn FDA-conditionally-approved animal drug for a minor species or a minor use in a major species
Legally Marketed Unapproved New Animal Drugs for M[inor Species]FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor SpeciesAn FDA-authorized product for a non-food-producing minor species or an early life stage of a food-producing minor species
Unapproved Drug Other;
Unapproved Medical Gas; or
Unapproved Homeopathic
 
No application and illegally marketedNot approved by FDA

The six-digit application number for an approved drug, conditionally approved drug, or approved biologic product is listed in the column with the header, “Application Number or Regulatory Citation.”

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 reviewed the safety or effectiveness of the product or approved the product's labeling.

For each drug in the repository, there is a “Marketing Information” box beneath the label. This box contains the marketing category of the drug. For an approved drug, conditionally approved drug, or approved biologic product, this box also contains the application number.

More tips on using the label to tell if a drug is FDA-approved for animals.

DailyMed, a website run by the National Library of Medicine, includes labels for marketed human and animal drugs, but does not contain a complete listing of labels. Using DailyMed, you can search for a drug’s label by drug name (trade name or established name) or National Drug Code (NDC) number. When the search results come up, click on a specific drug to view the label information. The “Marketing Status” box on the top right contains similar information to the “Marketing Category” column described above for the FDA Online Label Repository. This information will tell you if the drug is approved.

To differentiate animal drugs from human drugs, DailyMed identifies animal drugs, both approved and unapproved, by the header, “Veterinary Medicine Labels,” at the top of the page.
 

What is a drug’s “trade name” versus its “established name”?

A drug’s “trade name” is chosen by the drug company and is the name the company uses to market the drug. The trade name is also called the drug’s proprietary name. A drug’s “established name” is the drug’s active ingredient. The established name is also called the drug’s generic name. Please note that a generic name is not the same as a generic drug. A generic drug is an FDA-approved copy of a brand name drug.

Here are a few examples to help you keep the types of names straight:
 

 Trade NameProprietary NameEstablished NameActive IngredientGeneric Name
Comfortis®AComfortis®spinosadspinosadspinosad
Heartgard® TabletsBHeartgard® Tabletsivermectinivermectinivermectin
Iverhart™ TabletsCIverhart™ Tabletsivermectinivermectinivermectin
AFlea product for dogs marketed by Elanco Animal Health, A Division of Eli Lilly & Co. under NADA 141-277.
BHeartworm preventive for dogs marketed by Merial Ltd. under NADA 138-412.
CHeartworm preventive for dogs marketed by Virbac AH, Inc. under ANADA 200-270. Iverhart™ Tablets are a generic copy of Heartgard® Tablets.