definiens: means : ( i ) in the United States, with respect to a pharmaceutical product that has been approved under Section 505(c ) of the FFDCA ( i.e., a application under 505(b)(1 ) or an applicati on under 505(b)(2 ) ), any other pharmaceutical product that i s sold under the Drug Approval Application for the first product or any supplement or amendment to such Drug Approva l Application, and that is marketed, sold or distri buted directly or indirectly to retail class of trade wit h labeling, packaging ( other than repackaging as th e listed drug in blister packs, unit doses or similar packaging for use in institutions ), product code, labeler code, t rade name or Trademark that differs from that of the listed phar maceutical product ; or ( ii ) with respect to a pharmaceutical prod uct sold outside the United States, any other pharmaceutical product that is identical in t erms of the qualitative and quantitative compositio n of the active substance(s ) and the pharmaceutical form to the fir st product and that is sold under the Drug Approval Application for the first product or any supplement or amendmen t to such Drug Approval Application, and that is ma rketed, sold or distributed directly or indirectly to retai l class of trade with labeling, packaging, product code, labeler code, trade name or Trademark that differs from that of t he listed pharmaceutical product