definiens: ..... 1 ] .... ve the mealllnllllCI fonh In Secuon 10.2(1 ) . 1.16 -NDA " ofa ProdUCI shall mean a New DruS Applic.liOfl as 4efined in Title 21 of the U.S. Code of Fedcml Regulations . § 314.80 CI seq ., and alllllllCOOl"l1oCll1I and supplcments therelo . which is filed with Ihe FDA, or the equivalenl application filed wilh I ~ eallh Canada in CIIJIIOdn, iJlcludingll1l dOCUlllCllU. data, and other infOmt : llio n concerning such I'roduci thus filed lh.~1 un : tlI.'CClloSill ) ' for gaining Mmelins Approval for luch Product