first applicant
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355 — under this section (12 versions over time)
As used in this subsection, the term “first applicant” means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.