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 ..... FOOD _ DR_ 21  355
 (|v) If a supp_ment to an applic_on approved under subsection (b} of thk section
 approved after September 24_ 1984, and the supptemen_ contaivs reports of re_w
 clinical mvestigatior_ (other than bioavsi|ability studies) essen_a] to the approval of
 the supplement and conducted or sponsored by the person subra:itting the supple
 ment_ the Secretary may not make the approval of an app|ic_ttJon submitted under
 th_ subsection for s change approved m the supplement effective before the
 expL_tion of three year from the date of the approval of the supplement under
 subsection (b) of th_ sec_on.
 (v) If sn _p]ic_tiun (or supplement to _n application) submitted under subsection
 _b) of _ sect/on for _ drug, which h_cludes _n active ingredient (_,c|u_ng auy ester
 or _lt of the active ingredient) that hag been approved m another applicator usder
 suhsectmn (b) of th_ sectkm, was approved during the period beginning January I,
 1982_ and endS_g on September 24, 1%_4, the Secretary may not make the approval of
 _n application _ub_'dtted under this _ubsect_on wMch refe_ m the drug for which
 the subsec_un (b) applic_t,ion was submitted e_ which refers _ _ change approved
 a supplement to the _ubsect_on (b) applic_tion effe_ve before the expiration of two
 years from September 24, 19_.
 (_) If a drug approved under this subsection refers in its approved applica_on t_ a
 drug the approval of which s,_ withdrawn or suspended for g'mun_ descry'bed h_
 the first sentence of subsection {e) of this section or was w_thdr_w_ or suspended
 under th_ paragraph or which, as determined by the Secre_ry, hs_s been withdrawn
 from sale for safety or effectiveness re_.sons, the approval of the drug under this
 subsection shall be w_thdr_w_ or suspended_
 (A) for the _me period as the w_thdruwal or suspension under subsection {e)
 of this section or this paragraph, or
 (B) if the listed drug has been withdrawn from _le_ _or the period of
 vdthdrawel from sale or, _f earlier, the period ending o_ the date the Secretary
 determinea that _e _thdrawal from sale _ not for _fet_ or effedtiveness
 (_)(A)(D Within sixty days of September 24, 19g_, the ae_retac/_h_ publ_sh and
 make available to the public_
 (1) a lit _a a_phabet_ccal order of the official and prepr_etary name of each
 drug which has been approved for safe_ and effecgveness under _ubsec_on @)
 of this section before September 24, 1984;
 {|I) the date of approvM if the &_g is app_ved after 1951 and the number of
 the sppfication which was approved; and
 (I|D whether in v_t_v or in _vo bioequivalence studies, or both such s_udi_,
 are required for app_c_fions fried under this subsection which will refer _ the
 drug pub_hed.
 (ID Eve_ thh_y days _ter the publication of the first list under clause (f_ the
 Secre_ry shall revise the _t _ _nc|ude _sch drug wh_.ch has been approved for
 safety and effectiveness under subsection () of this section or approved under
 subsection during the thh'ty..dsy period.
 (ill) When paint inferma_on submitted render subsection (b) cr {c) of th_ section
 respecting a drug included on the _t _ to be published by the Secretary the
 _eexet._" shall, m revisions trade under clause (fi), include such _|formation for _uch
 drug,
 (B) A drug spproved for _afety and effectiveness trader _ubeect_o_ (c} of thk
 _ec'_ian or approved under thin aubsect_on _ha_i, for purp_:_es of _h_ subsectiua, be
 _ns_dere_ _ have been published under subparagraph (A) on the clan of _._
 approval or September 24, 19_, whichever _$ last.
 (C) If the approva_ _f a drug was _dthdza_ or suspended for grounds described
 the first _ntence of subsection (e) of this section or was withdrawn or suspended
 under paragraph (_ or if the ,_eretary determhues that a drug has been withdrswu
 from sale far safety or effectiveness reason, it may not be _ubl_shed in the _t
 ueder subps._-_graph (A) or, if the _dthdrswa| or auspension _curred _ its
 publication in auah Rst_ R ahall be _mmed_ately removed from such lists
 (D for the same period _ the withdruwal or suspension under subsection (e}
 of thin section or paragraph (_ or
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