approved drug
(5) (A) If an application is submitted under section 360e or 360(k) of this title or a request is submitted under section 360c(f)(2) of this title , consistent with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved drug— (i) the application or request shall include the certification or statement described in section 355(b)(2) of this title ; and (ii) the applicant or requester shall provide notice as described in section 355(b)(3) of this title . (B) For purposes of this paragraph and paragraph (4), the term “approved drug” means an active ingredient— (i) that was in an application previously approved under section 355(c) of this title ; (ii) where such application is relied upon by the applicant submitting the application or request described in subparagraph (A); (iii) for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and (iv) for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by or for whom the investigations described in clause (iii) were conducted. (C) The following provisions shall apply with respect to an application or request described in subparagraph (A) to the same extent and in the same manner as if such application or request were an application described in section 355(b)(2) of this title that referenced the approved drug: (i) Subparagraphs (A), (B), (C), and (D) of section 355(c)(3) of this title . (ii) Clauses (ii), (iii), and (iv) of section 355(c)(3)(E) of this title . (iii) Subsections (b) and (c) of section 355a of this title . (iv) Section 355f(a) of this title . (v) Section 360cc(a) of this title . (D) Notwithstanding any other provision of this subsection, an application or request for classification for a combination product described in subparagraph (A) shall be considered an application submitted under section 355(b)(2) of this title for purposes of section 271(e)(2)(A) of title 35 .