; or (bb) approval of a drug that was approved under section 505 (except for an approval changing a drug from prescription to nonprescription status); and (II) do not duplicate the results of another study that was relied on by the Secretary to support— (aa) a proposed or final determination that a drug described in subclauses (I), (II), or (III) of clause (iii) is generally recognized as safe and effective within the meaning of section 201(p)(1); or (bb) approval of a drug that was approved under section 505 (except for an approval changing a drug from prescription to nonprescription status). (vi) Effective date A final order subject to clause (i) shall take effect on the date when the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to such order) submits updated drug listing information under subsection (e) with respect to the change which is permitted under such order. (6) Information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request (A) In general In response to a request under this section that a drug described in subparagraph (B) be generally recognized as safe and effective, the Secretary— (i) may file such request, if the request includes information specified under subparagraph (C) with respect to safe nonprescription marketing and use of such drug; or (ii) if the request fails to include information specified under subparagraph (C), shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph (D). (B) Drug described A drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug— (i) specified in subsection (a)(1), (a)(2), or (a)(3); (ii) subject to a final order under this section