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 FOOD AND,DRVGS 21 § 355
 _how that the _fi.ffere_t active ingredient _ _ active ingredient of a I_t_
 drug or of a drug which does not meet the requiremen_ of sectior_ 321(p) of _is
 title, and such other information respecting the different active ingredient with
 respac_ to which the petition was filed as the Secreh_xy may require;
 (Hi) information to show _ the route of administration_ the dosage form,
 and the strength of the new drug are the same as those of the lhted drug
 referred to in clause (i) or, if the route of administzagon_ the dosage forts, or the
 strength of the new drug is different mad the application is filed p_rsuant'to the
 approval of a pe_tion filed "under subparagraph (CC), such information respecting
 the rou_ of adxninistrut_on_ dosage form, or strength with re_pec,_ to which the
 pe_tion was fi)ed _s the Secretary may require;
 (_v) h_forma_on to show that the new drug is bioequNalent to _e _ted drug
 referred to in clause (i}, except that £f the application is filed pursuant to the
 approved of a petition filed under subpgragrmph (C)_ information to _how that the
 act/re ingredient_ of the new drug _e of the same pharmacological or thezmtpeu-
 tic class as those of the listed drug referred to in clause {i) and the :mew drug can
 be expected to have the same therapeutic effect as the listed drug when
 administered to patients for a condition of use referred to in chu_;e (i);
 (v) information to show that the labeling proposed for the new drug _s the
 same as the hbeling approved for the listed drug referred to in cla_e (i) except
 for changes requhred because of differences approved under a -_etitiou filed
 under suhpar_g_ph {C) or because the new drug and the l_s_d drug are
 produced or distributed by different _aauf_c_urer_;
 (v}) the items specified in clauses (B) through (F) of subsectio_ (b)_i) of this
 section;
 (vii) $ certification, in the opinion of the applicant and _ the best of his
 knowledge, w_ respect to each patent which claims the listed drug referred to
 in clause (i) or which claims a use for such listed drug for which the applicant is
 seeking appreva_ under thig subsection and for which information is required to
 be f_ed under subsection _b) or (c) of this sections
 (D that such paze_t reformation has _o_ been filed,
 (|{) that such patent has expired,
 (Ill) of _e date on which such pa_n_ will expire, or
 (IV) that such patent is h_valid or will _o_: be _nf_nged by the manufac-
 ture, use_ or san of the new drug for which the application is submi_,ed;
 and
 (v_tD if with respect go the listed drug referred to in d_u_e {i) information
 was filed under subsection _b) or (c) of this _ection for a method of use patent
 which does not claim _ use for which the _pplicz:n_ is seeking approval under this
 subsection, a statement that the method of use patent does not claim such a use.
 The Secreta_ may not require tha_ an abbrevhted application contain information _n
 addition to theft required by chuse_ (_ through (_4fi).
 e
 (_i) An applicaag who makes a _rtification described in subparagraph
 (AXvi/XIV) shall _nclude in the application a statement that the applicant will give the
 :. notice requ/red by clause (ii)
 {D each owner of the patent which is the suhjevt of the certification or the
 represen_ve of such owner designated to receive such notice_ and
 (l]) the holder of the approved app}{cat_o_ under subsection {b) of this sec_on
 for the drug which is claimed by the l:,_tent or a use of which _ ctair_ed by the
 patent or the representative of such homer designated _ receive such notice.
 (fi) The _otice referred to in clause (i) shaB _tat_ that an application: wldch
 cont_s data from bio_vafiabfii_y or b_oequivalesce studSes, has been submitted
 under this subsection for _e drug with respect to which the certification is made to
 obtain approval to engage in the commercial manufacture, use, or sale of such drug
 before the exph',ation of the patent referred to in the certification. Such notice shMI
 include a deta/led s_temeat of the factual and _egal basis of the applicant's opinion
 that the patent is not valid or will{ not be infringed°
 (i{|) If an appl_cation is amended to include a ce_:/fication descr/bed in subpar_.
 graph (AXviiXrV), the nonce required by clause (5) sh._ be given when the amended
 .... application is submitted.
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