Glossary

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  • New Drug Application (NDA)

    When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.  For internal tracking purposes, all NDA's are assigned an NDA number.

  • New Drug Application (NDA) Number

    This six digit number is assigned by FDA staff to each application for approval to market a new  drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. In Drugs@FDA, you can find the NDA number under the column named "FDA Application."

  • New Molecular Entity (NME)

    A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.