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The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification