definiens: means : ( i ) in the United States, with respect to a pharmaceutical product that hasbeen approved under Section 505(c ) of the FFDCA ( i.e., a application under 505(b)(1 ) or an application under505(b)(2 ) ), any other pharmaceutical product that is sold under the Drug Approval Application for the first product orany supplement or amendment to such Drug Approval Application, and that is marketed, sold or distributed directly orindirectly to retail class of trade with labeling, packaging ( other than repackaging as the listed drug in blister packs, unit doses or similar packaging for use in institutions ), product code, labeler code, trade name or Trademark thatdiffers from that of the listed pharmaceutical product ; or ( ii ) with respect to a pharmaceutical product sold outside the United States, any other pharmaceutical product that is identical in terms of the qualitative and quantitative composition of the activesubstance(s ) and the pharmaceutical form to the first product and that is sold under the Drug Approval Application forthe first product or any supplement or amendment to such Drug Approval Application, and that is marketed, sold ordistributed directly or indirectly to retail class of trade with labeling, packaging, product code, labeler code, trade nameor Trademark that differs from that of the listed pharmaceutical product