### Question
Can you define what first approved applicant means?


### Answer
**First approved applicant** is defined as the following in *21 U.S.C. § 355*:

> any applicant that has submitted an application that—


(AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved

#### Citation:
  - *21 U.S.C. § 355*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

