FDA OrangeBook code

U-1987

METHOD OF CONTROLLING GLYCEMIA IN DIABETICS BY ADMINISTERING AN INITIAL DOSE OF INSULIN-FDKP WITH A MEAL; DETERMINING BLOOD GLUCOSE LEVEL 1-2 HRS AFTER AND ADMINISTERING A SUPPLEMENTAL DOSE OF INSULIN-FDKP IF POSTPRANDIAL GLUCOSE LEVEL IS >140 MG/DL