Applicant

Applicant means any person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application.

Source

21 CFR § 314.3


Scoping language

The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part.

Is this correct? or