FDA — authorised 13 July 1983
- Application: NDA022046
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bupivacaine Hydrochloride And Epinephrine in United States
FDA authorised Bupivacaine Hydrochloride And Epinephrine on 13 July 1983
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 1 February 2021
- Application: NDA204803
- Marketing authorisation holder: INNOCOLL
- Local brand name: POSIMIR
- Indication: SOLUTION — INFILTRATION
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA204842
- Marketing authorisation holder: HIKMA PHARMS
- Status: approved
FDA — authorised 12 May 2021
- Application: NDA211988
- Marketing authorisation holder: HERON THERAPS INC
- Local brand name: ZYNRELEF KIT
- Indication: SOLUTION, EXTENDED RELEASE — PERIARTICULAR
- 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.
Other Ophthalmology approved in United States
Frequently asked questions
Is Bupivacaine Hydrochloride And Epinephrine approved in United States?
Yes. FDA authorised it on 13 July 1983; 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.