U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Regulation Overview
New Drug Application

What is a New Drug Application?

The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.

The documentation required in an NDA is supposed to tell the drug's whole story, including:

An assortment of OTC drugs, including liquids, pills, and creams.
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