FUDANTIN (Nova Pharmaceuticals Australasia Pty Ltd)
Product name
FUDANTIN
Date registered
Evaluation commenced
Decision date
Approval time
134 (255 working days)
Active ingredients
nitrofurantoin
Registration type
New generic medicine
Indication
Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.