definiens: means the FDA ’s publication ( r ) means : ( i ) ANDA No . 208757 for 1 2 mg/0.6 mL methylnaltrexone bromide in a single - dose vial product ; and ( ii ) any ANDA filed by [COMPANY] for 8 mg/0.4 mL and/or 12 mg/0.6 mL methyln altrexone bromide in a single - dose pre - filled syringe for whi ch Relistor ® Injection is the Reference Listed Drug, and, with respect to ( i ) and ( ii ), including any amendments, replacements, or supplements that have been made or may in the future be made thereto . For clarity, or means with respect to an ANDA for 12 mg/0.6 mL methylnaltrexone bromide in a single - dose vial product for which Relistor ® Injection is the Reference Listed Drug