FDA — authorised 19 November 1948
- Application: NDA006488
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: XYLOCAINE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bupivacaine Hydrochloride And Epinephrine in United States
FDA authorised Bupivacaine Hydrochloride And Epinephrine on 19 November 1948
Marketing authorisations
FDA — authorised 19 November 1948
- Application: NDA021381
- Marketing authorisation holder: DENTSPLY PHARM
- Local brand name: XYLOCAINE DENTAL WITH EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 1951
- Application: NDA007942
- Marketing authorisation holder: FOREST LABS
- Local brand name: SUS-PHRINE SULFITE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 August 1969
- Application: NDA016803
- Marketing authorisation holder: STERLING
- Local brand name: BRONKAID MIST
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 23 February 1972
- Application: ANDA080504
- Marketing authorisation holder: BELMORA LLC
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 1972
- Application: ANDA080406
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 1972
- Application: NDA010418
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: XYLOCAINE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1972
- Application: ANDA083154
- Marketing authorisation holder: ABBOTT
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 1973
- Application: ANDA080759
- Marketing authorisation holder: BEL MAR
- Local brand name: PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 1973
- Application: ANDA080757
- Marketing authorisation holder: BEL MAR
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 1973
- Application: ANDA080758
- Marketing authorisation holder: BEL MAR
- Local brand name: PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 1973
- Application: ANDA080820
- Marketing authorisation holder: BEL MAR
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 1975
- Application: ANDA083389
- Marketing authorisation holder: DELL LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 1975
- Application: ANDA083390
- Marketing authorisation holder: DELL LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 January 1976
- Application: ANDA084720
- Marketing authorisation holder: CARLISLE
- Local brand name: ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 January 1976
- Application: ANDA084732
- Marketing authorisation holder: CARLISLE
- Local brand name: ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 February 1980
- Application: ANDA086402
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 1983
- Application: NDA022046
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 1983
- Application: ANDA084728
- Marketing authorisation holder: PHARMATON
- Local brand name: LIDOCATON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 1983
- Application: ANDA084729
- Marketing authorisation holder: PHARMATON
- Local brand name: LIDOCATON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 1984
- Application: ANDA087907
- Marketing authorisation holder: ARMSTRONG PHARMS
- Local brand name: EPINEPHRINE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 13 September 1985
- Application: ANDA088571
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 1987
- Application: NDA019430
- Marketing authorisation holder: VIATRIS
- Local brand name: EPIPEN JR.
- Indication: INJECTABLE — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071171
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071165
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071166
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071167
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071168
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071169
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA071170
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089650
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089635
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089649
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089645
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089644
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089651
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1988
- Application: ANDA089646
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1993
- Application: ANDA040057
- Marketing authorisation holder: EASTMAN KODAK
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 1995
- Application: NDA020530
- Marketing authorisation holder: IOMED
- Local brand name: IONTOCAINE
- Indication: SOLUTION — IONTOPHORESIS
- Status: approved
FDA — authorised 30 May 2003
- Application: NDA020800
- Marketing authorisation holder: IMPAX
- Local brand name: TWINJECT
- Indication: INJECTABLE — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 6 May 2004
- Application: NDA021504
- Marketing authorisation holder: VYTERIS
- Local brand name: LIDOSITE TOPICAL SYSTEM KIT
- Indication: PATCH — IONTOPHORESIS, TOPICAL
- Status: approved
FDA — authorised 26 October 2004
- Application: NDA021486
- Marketing authorisation holder: EMPI
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: SOLUTION — IONTOPHORESIS, TOPICAL
- Status: approved
FDA — authorised 30 March 2006
- Application: NDA020971
- Marketing authorisation holder: DEPROCO
- Indication: Labeling
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA078959
- Marketing authorisation holder: SEPTODONT INC
- Status: approved
FDA — authorised 10 August 2012
- Application: NDA201739
- Marketing authorisation holder: KALEO INC
- Local brand name: AUVI-Q
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 15 June 2017
- Application: NDA207534
- Marketing authorisation holder: ADAMIS PHARMS CORP
- Local brand name: SYMJEPI
- Indication: SOLUTION — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 6 July 2018
- Application: ANDA207568
- Marketing authorisation holder: AM REGENT
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 16 August 2018
- Application: ANDA090589
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EPINEPHRINE (AUTOINJECTOR)
- Indication: INJECTABLE — INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 5 November 2019
- Application: NDA209359
- Marketing authorisation holder: HOSPIRA
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 24 April 2020
- Application: ANDA211880
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 8 September 2021
- Application: ANDA208475
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 August 2022
- Application: NDA211363
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 September 2024
- Application: ANDA217192
- Marketing authorisation holder: AM REGENT
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 20 November 2024
- Application: ANDA213708
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 6 February 2025
- Application: ANDA219239
- Marketing authorisation holder: GLAND
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 28 February 2025
- Application: NDA218475
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Bupivacaine Hydrochloride And Epinephrine for marketing by BAXTER HLTHCARE CORP on 2025-02-28. This approval was granted under the Type 5 indication, which covers new formulations or new manufacturers. The application number for this approval is NDA218475.
FDA — authorised 13 March 2025
- Application: NDA215425
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA218144
- Marketing authorisation holder: GLAND
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS
- Status: approved
FDA — authorised 14 October 2025
- Application: ANDA217485
- Marketing authorisation holder: AMNEAL
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 8 December 2025
- Application: ANDA218208
- Marketing authorisation holder: AMNEAL
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 30 March 2026
- Application: NDA220626
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA208908
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: EPINEPHRINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA085463
- Marketing authorisation holder: WATSON LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
- Indication: INJECTABLE — INJECTION
- 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 Neuroscience approved in United States
Frequently asked questions
Is Bupivacaine Hydrochloride And Epinephrine approved in United States?
Yes. FDA authorised it on 19 November 1948; FDA authorised it on 19 November 1948; FDA authorised it on 8 June 1951.
Who is the marketing authorisation holder for Bupivacaine Hydrochloride And Epinephrine in United States?
FRESENIUS KABI USA holds the US marketing authorisation.