URODANTIN, NITROFURANTOIN B&B, NITROFURANTOIN MLABS, NITRODANTIN, NITRODANTIN (Micro Labs Pty Ltd)
Product name
URODANTIN, NITROFURANTOIN B&B, NITROFURANTOIN MLABS, NITRODANTIN, NITRODANTIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
148 working days (255)
Active ingredients
Nitrofurantoin
Registration type
New generic medicine
Indication
URODANTIN, NITROFURANTOIN B&B, NITROFURANTOIN MLABS, NITRODANTIN (capsules) are indicated for the 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.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine