FDA — authorised 30 December 1981
- Application: NDA018304
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 0.5% Bupivicaine in United States
FDA authorised 0.5% Bupivicaine on 30 December 1981
Marketing authorisations
FDA — authorised 4 May 1984
- Application: NDA018692
- Marketing authorisation holder: HOSPIRA
- Local brand name: MARCAINE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 21 May 1986
- Application: ANDA070553
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 May 1986
- Application: ANDA070552
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 May 1986
- Application: ANDA070554
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 1987
- Application: ANDA071202
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 13 October 1987
- Application: ANDA070968
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 October 1987
- Application: ANDA070966
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 October 1987
- Application: ANDA070967
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SENSORCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
0.5% Bupivicaine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is 0.5% Bupivicaine approved in United States?
Yes. FDA authorised it on 30 December 1981; FDA authorised it on 4 May 1984; FDA authorised it on 21 May 1986.
Who is the marketing authorisation holder for 0.5% Bupivicaine in United States?
FRESENIUS KABI USA holds the US marketing authorisation.