### Question
How is the "approved drug" defined?


### Answer
The term **approved drug** is defined in *21 U.S.C. § 353* as follows -

> an active ingredient—


(i) that was in an application previously approved under section 355(c) of this title

#### Citation:
  - *21 U.S.C. § 353*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

