definiens: shall mean : ( i ) the Abbreviated New Drug Applications, which reference the product approved under New Drug Application 21 - 249, to be filed with the FDA by [COMPANY] or any of its Affiliates in order to obtain approval to manufacture and/or selliovastatin 20mg / niacinll gm, lovastatin 20 mg / niacin 750 mg and lovastatin 20mg / niacin 500 mg extended release oral tablets ( and any supplement or amendment filed pursuant to FDA requirements ) ; and ( ii ) any other Abbreviated New Drug Application filed with the FDA by [COMPANY] or any of its Affiliates in order to obtain approval to manufacture and/or sell any oral dosage form containing niacin ( empirical formula of C6HSN02 ) and lovastatin ( empirical formula of C : Wi360S ) as the only active ingredients ( and any supplement or amendment filed pursuant to FDA requirements )