FDA — authorised 17 April 1978
- Application: NDA018053
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BUPIVACAINE HYDROCHLORIDE in United States
FDA authorised BUPIVACAINE HYDROCHLORIDE on 17 April 1978
Marketing authorisations
FDA — authorised 13 July 1983
- Application: NDA022046
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA070609
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 December 1987
- Application: ANDA071810
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 3 September 1992
- Application: NDA019978
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE KIT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 January 2002
- Application: ANDA076012
- Marketing authorisation holder: INTL MEDICATED
- Local brand name: BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 2003
- Application: NDA021496
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: DUOCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 October 2011
- Application: ANDA091487
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 October 2011
- Application: ANDA091503
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 2016
- Application: ANDA207183
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2016
- Application: ANDA207266
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 19 February 2019
- Application: ANDA211096
- Marketing authorisation holder: CIVICA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 April 2019
- Application: ANDA209087
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 30 December 2019
- Application: ANDA212822
- Marketing authorisation holder: HUONS
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — SPINAL
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA204842
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA205141
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 2023
- Application: ANDA216039
- Marketing authorisation holder: MEITHEAL
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 2023
- Application: ANDA217792
- Marketing authorisation holder: SOMERSET
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 December 2023
- Application: ANDA216040
- Marketing authorisation holder: MEITHEAL
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 2024
- Application: ANDA217821
- Marketing authorisation holder: ASPIRO
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 2026
- Application: ANDA220493
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: BUPIVACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
BUPIVACAINE HYDROCHLORIDE 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 approved in United States?
Yes. FDA authorised it on 17 April 1978; FDA authorised it on 13 July 1983; FDA authorised it on 3 March 1987.
Who is the marketing authorisation holder for BUPIVACAINE HYDROCHLORIDE in United States?
HOSPIRA holds the US marketing authorisation.