Applicant means, for the purposes of this subpart, a person holding an application under which a combination product or constituent part of a combination product has received marketing authorization (such as approval, licensure, or clearance). For the purposes of this subpart, applicant is used interchangeably with the term you.


21 CFR § 4.101

Scoping language

Abbreviated new drug application (ANDA) has the same meaning given the term abbreviated application in 314.3 of this chapter.

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