UBISTESIN FORTE articaine HCl 4% with adrenaline (epinephrine) 1:100,000 solution for injection cartridge, 3M Australia Pty Ltd , CON-690
Product name
UBISTESIN FORTE articaine HCl 4% with adrenaline (epinephrine) 1:100,000 solution for injection cartridge
Sponsor name
3M Australia Pty Ltd
Consent start
Consent no.
CON-690
Standard
USP monograph for Articaine Hydrochloride and Epinephrine Injection
Non-compliance with standard
They may not meet the adrenaline (epinephrine) sulfonic acid impurity limit of
not more than 7.5% and, consequentially, the total impurity limit of not more
than 10% at shelf life.
Therapeutic product type
Prescription medicines