### Question
How does the law define abbreviated drug application?


### Answer
Under *21 U.S.C. § 321*, **abbreviated drug application** is defined as:

> an application submitted under section 355(j) or 357 of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and—


(1) in the case of section 335a of this title, includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and


(2) in the case of sections 335b and 335c of this title, includes any supplement to such an application

#### Citation:
  - *21 U.S.C. § 321*
  - Heading: **CHAPTER 8-NARCOTIC FARMS > SUBCHAPTER II-DEFINITIONS**

