FDA — authorised 3 October 1972
- Application: NDA016964
- Marketing authorisation holder: HOSPIRA
- Local brand name: MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bupivacaine Hydrochloride And Epinephrine in United States
FDA authorised Bupivacaine Hydrochloride And Epinephrine on 3 October 1972
Marketing authorisations
FDA — authorised 26 June 1987
- Application: NDA018692
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 October 1987
- Application: ANDA070554
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 December 1990
- Application: ANDA070553
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 3 September 1991
- Application: ANDA070552
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA204842
- Marketing authorisation holder: HIKMA PHARMS
- Status: approved
Bupivacaine Hydrochloride And Epinephrine 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 Bupivacaine Hydrochloride And Epinephrine approved in United States?
Yes. FDA authorised it on 3 October 1972; FDA authorised it on 26 June 1987; FDA authorised it on 14 October 1987.
Who is the marketing authorisation holder for Bupivacaine Hydrochloride And Epinephrine in United States?
HOSPIRA holds the US marketing authorisation.