; or (bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective within the meaning of section 201(p)(1), which is filed by the Secretary under subparagraph (A)(ii). (ii) Exception The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective within the meaning of section 201(p)(1) under paragraph (1) and issues a final order announcing that determination. (iii) Withdrawal The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to subsection (d)(2)(B). Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary may cease proceedings under this subparagraph. (C) Exclusivity (i) In general A final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order), for a period of 18 months following the effective date of such final order, to market drugs— (I) incorporating changes described in clause (ii); (II) beginning on the date the requestor (or any such licensees, assignees, or successors in interest) may lawfully market such drugs pursuant to the order; and (III) subject to the limitations under clause (iv). (ii) Changes described A change described in this clause is a change subject to an order specified in clause (i), which— (I) provides for a drug to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a drug described in clause (iii)