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 FOOD _D wvc_ 21 § 355
 (G) informa_on submitted m the appUication/s i_ffieient to show that the
 _abelisg proposed for the drug ii the _tme _ the l_be]isg approved for the
 listed drug rsferzsd to h'i the &pp]ic_tion except for ch,,nges required because of
 diffe_n_ss approved under tt peti_on filed under paz_grsph (2XC) or because
 Me drug and the lintel drug sze produ_d or dmtribu_sd by diffe_nt ms_uf_
 {ll) _oz_ation submitted m the app|i_Zion or an)' other _o_ua_on av_i_
 able to the Secretary show_ tMtt (i) the inactive ing_dients of the drug srs
 strafe foz use under the conditior_ prescribed, x_cor_.mended, or sugges_d
 the labeling proposed for the drug, or (li) the composition of the drug _s u_fe
 un_ such conditio_ because of the type or quantity of inactive ingredients
 included or the maturer in which the i_sctive in_red_en_ sr_ included;
 G) the approva_ under esbe_on (e) of this section cf the listed drug refereed
 to _ the application tinder _ subsection has been withdxswu or suspended for
 greu_d_ described i_ the finer _ent_ne, of subsection (e) of this section, the
 Secr_ttry h_ pub|ished _ notice of opportunity for hearing to withdraw approv-
 al of the _ted drug under subsection (e} of this section for g_unds described in
 _he first sentries of subsection (e) of _is _ectiozL the approval under this
 subsection of the lined drug refer_d to m the a_ica_on under this subsection
 has been withdrawn or suspended under paragraph _5), or the Secretary has
 det_rm_ed that the listed drug h_ been wi_d._wn from sale for safety or *
 effectiveness reasons;
 (_) the application does nee meet any other r_qu_ernent of paragraph (2XA);
 (_) the appli_on contains an untrue statement of ma_al fact
 (_t_A) Within one hund_d _nd eighty days of the initial _eipt of _n appli_t_on
 under paragmtph (2) or within such additional period _s may be agreed upon by the
 _cr_t_ry and the applicant, the eecre_sxy ,hall approve or di, approve the applica- _
 (B) The _pp_oval of an appliec_on submitted under pa_t_'sph (2) shall be made
 ' effective on the l_t applicable _t_ det_nined under the following:
 (D If the applicant only made a certification described in subeiause (I) or (H)
 of paragraph (2){AXvi_) or in both such subelaus_s, th,_ approval may h, made
 effective immediately.
 (_i) tf the applicant made a eertifi_t,/on deathbed is subelause (]iX) of
 _r._gr_ph (2XAXvii), the _pp_va] may be made effective on the &tee certified
 .... under _uMMuse (HI)o
 (ii|) If the app]iec_nt made it cert.L_i_on descr_M_d is subelause (IV) of
 pa_g_'_ph (2_AXv_)0 the app_val shall b_ made effective immediately unless an
 _etion _ brought for infringement of s patent which m the subject of the
 cer,*Mi_t_o_ befo_ the expiation of _cr_y. five _y_ from the _ the notice
 • p_o_'id_l trader plr_gesph (2×BXi) _ received° if such an _on is brought
 be_oz_ the capitation of _uch days, the approval shall be made effectiva upon the
 expir_on of the thir_yomon_ period beginning on the dam of the _ceip_ of the
 no6_ t_a_vided under parg_r_ph (2_B_i) or such shorter or longer period _ the
 _u_ may o_er because either party _ the action failed _ re_onably coopei_
 at_ tn exp_di_ng the action, e_eep_ that_
 (D if before the e_pi_tion of _uch pe_dod the cou_ decides that such
 patent _s invslld or not tnfidnged, the approval shall b_ r_sde effective o_
 the _at_ of ths court _aebs_ou,
 (I|) If befo_ _e expir_tion of _uch p_iod _he _u_ d_ld_t that _ueh
 paint h_ been infringed, the approvd shill be made ¢ff_c_ve on ,ueh dam
 .... U the court ozxler_ under section _I(eX4_A) of Ti_e _ or
 (lID _ bef_r_ th, expiration of such period t_ c_u,rt _q'ant_ a p_lhui.
 _'y i_unction prohibi_g the applicant f_m engagdng m the ,ommerct_ll
 manufa_u_ or sale of the drug ust_l th, _u_ dE.idea the issues of patent
 validity and infringement and if the court decides _at such pa_n_ is invalid
 or not infringe, _e approval shall be made eff_t_ve on the da_ of euch
 couzt d_idon.
 I_ _ueh _m action, each of the _ee el'roll _owbiy coope_te in expedtt-
 _g th® se_Ono Until the expiation of forty.firs d.sy_ fz_m the _ th,

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