definiens: shall mean : ( i ) Abbreviated New Drug Applications Nos . 76 - 250 ( lgm tablets ) and 76 - 378 ( 500 and 750 mg tablets ) which reference the products approved under New Drug Application 20 - 381, filed with the FDA by [COMPANY] or any of its Affiliates in order to obtain approval to manufacture and/or sell Igm, 750 mg and/or 500 mg extended release oral niacin 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 fonn containing niacin ( empirical fonnula of CJ!sN02 ) as the single active ingredient ( and any supplement or amendment filed pursuant to FDA requirements )