Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
OXYBUTYNIN ARW, OXYBUTYNIN TIH, OXYBUPAN (Arrow Pharma Pty Ltd)
Product name
OXYBUTYNIN ARW, OXYBUTYNIN TIH, OXYBUPAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
180 working days (255)
Active ingredients
oxybutynin hydrochloride
Registration type
New generic medicine
Indication
OXYBUTYNIN ARW, OXYBUTYNIN TIH, OXYBUPAN (tablets) is indicated for the treatment of detrusor over-activity where conservative measures have failed.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine