FDA — authorised 11 March 1958
- Application: NDA010496
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: XYLOCAINE 5% W/ GLUCOSE 7.5%
- Indication: INJECTABLE — SPINAL
- Status: approved
🇺🇸 Lidocaine IV in United States
FDA authorised Lidocaine IV on 11 March 1958 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 15 September 1964
- Application: ANDA060567
- Marketing authorisation holder: PFIZER
- Local brand name: TERRAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 October 1969
- Application: NDA016801
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: XYLOCAINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 1972
- Application: ANDA080407
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 1972
- Application: ANDA080420
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 1972
- Application: ANDA080504
- Marketing authorisation holder: BELMORA LLC
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 April 1972
- Application: ANDA080409
- Marketing authorisation holder: HOSPIRA
- Local brand name: LTA II KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 11 December 1973
- Application: ANDA080710
- Marketing authorisation holder: BEL MAR
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 April 1974
- Application: ANDA080429
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ANESTACON
- Indication: JELLY — TOPICAL
- Status: approved
FDA — authorised 18 March 1975
- Application: ANDA083387
- Marketing authorisation holder: DELL LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 1975
- Application: ANDA083388
- Marketing authorisation holder: DELL LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1975
- Application: ANDA084626
- Marketing authorisation holder: ELKINS SINN
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 1975
- Application: ANDA084721
- Marketing authorisation holder: CARLISLE
- Local brand name: ALPHACAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 1976
- Application: ANDA085037
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 1976
- Application: ANDA085131
- Marketing authorisation holder: ELKINS SINN
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 1976
- Application: NDA017701
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 1977
- Application: ANDA080390
- Marketing authorisation holder: LYPHOMED
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1977
- Application: ANDA085995
- Marketing authorisation holder: HOSPIRA
- Local brand name: PEDIATRIC LTA KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 14 December 1979
- Application: ANDA086761
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 1980
- Application: ANDA086364
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: LARYNG-O-JET KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 9 May 1980
- Application: ANDA086578
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: LIDOCAINE HYDROCHLORIDE VISCOUS
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 August 1981
- Application: ANDA086724
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 2 February 1982
- Application: ANDA086389
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: LIDOCAINE HYDROCHLORIDE VISCOUS
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 November 1982
- Application: ANDA087872
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 November 1982
- Application: ANDA087881
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 February 1983
- Application: ANDA087980
- Marketing authorisation holder: ABBOTT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 June 1983
- Application: ANDA087931
- Marketing authorisation holder: KENDALL IL
- Local brand name: LARYNGOTRACHEAL ANESTHESIA KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 17 August 1983
- Application: ANDA084727
- Marketing authorisation holder: PHARMATON
- Local brand name: LIDOCATON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 May 1984
- Application: ANDA088294
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 1984
- Application: ANDA088331
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 1984
- Application: ANDA088330
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 1984
- Application: ANDA088329
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 May 1984
- Application: ANDA088328
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 1984
- Application: ANDA088542
- Marketing authorisation holder: HOSPIRA
- Local brand name: LTA II KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 31 July 1984
- Application: ANDA088572
- Marketing authorisation holder: ABBOTT
- Local brand name: PEDIATRIC LTA KIT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 9 July 1985
- Application: NDA018954
- Marketing authorisation holder: ABBOTT
- Local brand name: LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 May 1988
- Application: ANDA089362
- Marketing authorisation holder: ABBOTT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 1989
- Application: ANDA089688
- Marketing authorisation holder: PACO
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 April 1993
- Application: ANDA081318
- Marketing authorisation holder: COSETTE
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: JELLY — TOPICAL
- Status: approved
FDA — authorised 23 June 1995
- Application: ANDA040013
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 1995
- Application: ANDA040014
- Marketing authorisation holder: HIKMA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 September 1998
- Application: ANDA040302
- Marketing authorisation holder: HOSPIRA
- Local brand name: LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 2011
- Application: ANDA040837
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: JELLY — TOPICAL
- Status: approved
FDA — authorised 23 May 2011
- Application: ANDA040911
- Marketing authorisation holder: SEPTODONT INC
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 August 2012
- Application: ANDA200675
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
FDA — authorised 12 March 2014
- Application: ANDA204494
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 11 April 2014
- Application: ANDA202242
- Marketing authorisation holder: RISING
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 August 2015
- Application: ANDA206297
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 August 2015
- Application: ANDA091564
- Marketing authorisation holder: AM REGENT
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 March 2017
- Application: ANDA207810
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 20 September 2017
- Application: ANDA208604
- Marketing authorisation holder: RISING
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 October 2017
- Application: ANDA207182
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2018
- Application: ANDA208017
- Marketing authorisation holder: SPECTRA MDCL DEVICES
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA211469
- Marketing authorisation holder: ALEMBIC
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 12 December 2018
- Application: ANDA211019
- Marketing authorisation holder: COSETTE
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 17 October 2019
- Application: ANDA212486
- Marketing authorisation holder: GENEYORK PHARMS
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 March 2020
- Application: ANDA211697
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 May 2020
- Application: ANDA212821
- Marketing authorisation holder: HUONS
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 August 2020
- Application: ANDA206463
- Marketing authorisation holder: AMNEAL
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
FDA — authorised 1 December 2020
- Application: ANDA203265
- Marketing authorisation holder: NOVEN PHARMS INC
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
FDA — authorised 5 January 2021
- Application: ANDA208660
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LIDOCAINE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 29 April 2021
- Application: ANDA205882
- Marketing authorisation holder: NAL PHARM
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
FDA — authorised 8 November 2021
- Application: ANDA214339
- Marketing authorisation holder: ASPIRO
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 November 2021
- Application: ANDA214336
- Marketing authorisation holder: ASPIRO
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 June 2022
- Application: ANDA215132
- Marketing authorisation holder: AFAXYS
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2023
- Application: ANDA217692
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 July 2023
- Application: ANDA217693
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 December 2023
- Application: ANDA218182
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA218411
- Marketing authorisation holder: THE J MOLNER
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 April 2025
- Application: ANDA219535
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 October 2025
- Application: ANDA216484
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
FDA — authorised 9 February 2026
- Application: ANDA207059
- Marketing authorisation holder: USPHARMA
- Local brand name: LIDOCAINE
- Indication: PATCH — TOPICAL
- Status: approved
The FDA approved USPHARMA's application (ANDA207059) for Lidocaine IV on February 9, 2026. The approved indication is for topical use, as indicated by the PATCH — TOPICAL label. This approval allows USPHARMA to market Lidocaine IV in the United States under the brand name LIDOCAINE.
FDA — authorised 19 March 2026
- Application: ANDA220071
- Marketing authorisation holder: VIWIT PHARM
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Lidocaine Hydrochloride IV for injection, manufactured by VIWIT PHARM, on 19 March 2026. This approval was granted under the standard expedited pathway. The product is indicated for use as an injectable solution for local or regional anesthesia. The approval was based on an application number of ANDA220071.
FDA — authorised 20 March 2026
- Application: ANDA218676
- Marketing authorisation holder: QUAGEN
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
The FDA approved QUAGEN's application (ANDA218676) for Lidocaine Hydrochloride IV solution for oral use on 20 March 2026. This approval allows QUAGEN to market Lidocaine Hydrochloride under the brand name LIDOCAINE HYDROCHLORIDE. The solution is indicated for oral use, but the exact use case is not specified in the available information.
FDA
- Application: ANDA080414
- Marketing authorisation holder: MILES
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083627
- Marketing authorisation holder: WATSON LABS
- Local brand name: LIDOCAINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 10
Most-reported reactions
- Anaphylactic Shock — 1 report (10%)
- Brain Injury — 1 report (10%)
- Cerebrovascular Accident — 1 report (10%)
- Chills — 1 report (10%)
- Diplopia — 1 report (10%)
- Drug Effect Decreased — 1 report (10%)
- Idiosyncratic Drug Reaction — 1 report (10%)
- Memory Impairment — 1 report (10%)
- Myalgia — 1 report (10%)
- Postoperative Fever — 1 report (10%)
Lidocaine IV 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 Lidocaine IV approved in United States?
Yes. FDA authorised it on 11 March 1958; FDA authorised it on 15 September 1964; FDA authorised it on 6 October 1969.
Who is the marketing authorisation holder for Lidocaine IV in United States?
ASTRAZENECA holds the US marketing authorisation.