### Question
What is the definition of abbreviated drug application?


### Answer
The definition of **abbreviated drug application** is as follows in *21 U.S.C. § 321*:

> an application submitted under section 355(j) 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 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER II-DEFINITIONS**

