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 21  355 _oD AND DRUOS
 (C) If a pe_on wants to submit an abbreviated appHcat_or_ for a new drug which
 ha8 a different _e_ve ingr_nt or whose route of administa_a,_on, dosage forra_ or
 s'Lrength differ from that of a listed drug, such person sha|| _mbmit a pe._tiun to the
 Secretary seeking permissicn to file such an applic_tiom The Seezetm'y shsll
 approve _r disapprove a petition submitted under this subpa_graph within ninety
 days of the date the peti_on _ submitted. The S_e_ary shall approve such a
 pc_on unless the Seeze_d fmda--
 (D that investJga6oi_ mv_t be ecnductsd to show the s_ffe_ _md effectiveness
 of the drug or of any of its active ingredient, the route of adminiswation_ the
 dosage forra_ or s_xength whieh differ from the listed drt_g_ or
 (lfl} that any drug with a different _tive ingredient may not be adequately
 eva_uated for spprova] _ safe and effective on the b_ of the informatlon
  required to be submitted in an abbreviated applie_tiOno
 ($) Subject m paragruph (4)0 the Secretary shall app_ve an application for a drug
 "_m]ess the _ecreta_ fLn_
 (A) the methods used in, or the facilities and controls _sed for, the manufac-
 ture, processing, and packing of the drug are inadequam to assure and preserve
 its identity, strength, quaii_, and purity;
 (B) information submitted with the application is ins_ffi_ent to show that
 each of the proposed conditions of use have been previo_sly, approved for the
 l_ted drug referred _ in the application;
 (C)(i} _ the |isled drug ban only one active ingredient, information submitted
 with the app]ica_on Ls insufficient to _how that the active ingredient is the same
 as that of the listed drug;
 (_|) if the listed drug has more than one ac_ve ingredient, Lnformation
 submitted with the applica_on is insufficient to show that 'the active ingredients
 sre the same as the active ingredienL_ of the listed drag, or
 (ill) if the listed drug has more than one active ingredient and ff the
 app|ie_on is for a drug which has an active ingredient different from the listed
 drug, Lnformation submitxed with the applica_on m im, ufficient to show_
 {D that the other active ingredien_ are the same _ the ac_ve ingredi-
 enL_ of ?.he listed d.rug_ or
 (_I) that the different active ingredient is an active ingredient of a _ist_i
 drug or a drug which does not meet the requirements of section 321(p) of
 this _e_
 or no pegtion to fi_e an application for the drug with the different ingredient
 w_ approved uede_ paragraph (2_C};
 (D_i) ff the applic._on is for a drug whose route of administrstion_ dosage
 form, or strength of _e drug is the same _ the route of adminisr,rafion, dosage
 form, or strength of the listed drug referred to in the application, information
 _ubmit_d in the spp_ication is insufficient to show that the _u_ of administra-
 . rich, dosage form, or strength is the same _ that of the listed drug, or
 fit} if the application is for a drug whose rou_ of tdministza_on, dosage
 foera0 or strength ef the drug is different from that of the |L_d drug referred
 ...... _ in the appliea_on, no petition to file an application for the drug with the
 different mute of _immistraago_, dosage form, or _'ength _'_ approved under
 paragraph (2RC);
 (_) if the applicatiea was fried pursuant to the approv_ of a petit,ion under
 paragraph (2_C), the aIRplication did not contaL_ the informa_tioa _quired by the
 Secre_a_" respecting the strive ingredient, rou_ of admin_st_o_, d_age form,
 or strength wMch is not the same;
 (F) Mformat_on submitted h_ the application is insufficient _ show that the
 drug is bioequiva]ent to the _ed &'ug referred to L_ the appii_on or, ff the
 appiie._fien was filed pu_uant to a petition approved under par_gwph (2Xg)0
 hforraation submitted h't _'_e application is insufficient to show that the _tlve
 ingredie_ of the new dr_g are of the same pharmacological or therapeutic
 class _ those of the iL_ed drug refe_ed tem paragraph (2_A)(i) and that the
 new drug can be expected _ have the same _herapeugc effect as the listed drug
 when administered _ _tien_ for _ condition uf use r_ferred to in such
 paragraph;
 112 ( :*_ %,_-,




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