abbreviated drug application

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 321 — for the purposes of this chapter (13 versions over time)

The term “abbreviated drug application” means 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.