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Glossary · Tier 1

New Drug Application (NDA)

Also known as: NDA, NDA submission, NDA filing

Verified from FDA Drugs@FDA Glossary on 06-02-2026
Quick answer

The New Drug Application, or NDA, is the package of evidence a sponsor submits to the FDA when it believes a drug has accumulated enough safety and effectiveness data to qualify for marketing approval. It compiles technical review areas such as chemistry, pharmacology, medical, biopharmaceutics, and statistics, and each submission receives an NDA number for tracking. The FDA describes the application as follows.

MedivaScan summary. The authoritative source quote follows below.

FDA Drugs@FDA Glossary definition

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.

U.S. Food and Drug AdministrationView on source ›Verbatim quote. Last verified 06-02-2026.
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