How can I use the FDA Online Label Repository to tell if a drug is legally marketed?
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 drug|
|ANDA||Abbreviated New Drug Application||An FDA-approved generic human drug|
|BLA||Biologics License Application||An FDA-approved human therapeutic biologic produc|
|NADA||New Animal Drug Application||An FDA-approved animal drug|
|ANADA||Abbreviated New Animal Drug Application||An FDA-approved generic animal drug|
|Conditional NADA||Conditional New Animal Drug Application||An FDA-conditionally-approved animal drug for a minor species or a minor use in a major species|
|Legally 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 a non-food-producing minor species or an early life stage of a food-producing minor species|
|Unapproved Drug Other;
Unapproved Medical Gas; or
|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.
If the drug is an approved human or animal drug, a conditionally approved animal drug, or an approved human therapeutic biologic 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 biologic 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.