FDA — authorised 27 September 2006
- Application: ANDA077250
- Marketing authorisation holder: SEPTODONT
- Local brand name: VIVACAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Bupivacaine alone on 27 September 2006
Yes. FDA authorised it on 27 September 2006.
SEPTODONT holds the US marketing authorisation.