🇺🇸 Lidocaine post-embolization in United States

FDA authorised Lidocaine post-embolization on 2 September 1954

Marketing authorisations

FDA — authorised 2 September 1954

  • Application: NDA009470
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: XYLOCAINE VISCOUS
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

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

Read official source →

FDA — authorised 7 May 1959

  • Application: NDA010417
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: XYLOCAINE 4% PRESERVATIVE FREE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 15 September 1964

  • Application: ANDA060567
  • Marketing authorisation holder: PFIZER
  • Local brand name: TERRAMYCIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 6 October 1969

  • Application: NDA016801
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: XYLOCAINE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 14 February 1972

  • Application: ANDA080407
  • Marketing authorisation holder: WEST-WARD PHARMS INT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 15 February 1972

  • Application: ANDA080420
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 23 February 1972

  • Application: ANDA080504
  • Marketing authorisation holder: BELMORA LLC
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 6 April 1972

  • Application: ANDA080409
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LTA II KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 31 October 1972

  • Application: ANDA083158
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 27 December 1972

  • Application: ANDA083198
  • Marketing authorisation holder: LUITPOLD
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 11 December 1973

  • Application: ANDA080760
  • Marketing authorisation holder: BEL MAR
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 11 December 1973

  • Application: ANDA080710
  • Marketing authorisation holder: BEL MAR
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 11 April 1974

  • Application: ANDA080429
  • Marketing authorisation holder: BIONPHARMA
  • Local brand name: ANESTACON
  • Indication: JELLY — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 18 March 1975

  • Application: ANDA083388
  • Marketing authorisation holder: DELL LABS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 18 March 1975

  • Application: ANDA083387
  • Marketing authorisation holder: DELL LABS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 28 March 1975

  • Application: NDA017549
  • Marketing authorisation holder: MERIDIAN MEDCL TECHN
  • Local brand name: LIDOPEN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 30 April 1975

  • Application: ANDA084626
  • Marketing authorisation holder: ELKINS SINN
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 29 August 1975

  • Application: ANDA083083
  • Marketing authorisation holder: WYETH AYERST
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 September 1975

  • Application: ANDA083173
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 7 October 1975

  • Application: ANDA084721
  • Marketing authorisation holder: CARLISLE
  • Local brand name: ALPHACAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 29 July 1976

  • Application: ANDA085037
  • Marketing authorisation holder: EPIC PHARMA LLC
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 27 October 1976

  • Application: NDA017508
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 29 October 1976

  • Application: ANDA085131
  • Marketing authorisation holder: ELKINS SINN
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 3 December 1976

  • Application: NDA017701
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 14 March 1977

  • Application: ANDA080390
  • Marketing authorisation holder: LYPHOMED
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 November 1977

  • Application: ANDA085995
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: PEDIATRIC LTA KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 14 December 1979

  • Application: ANDA086761
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 6 March 1980

  • Application: ANDA086364
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: LARYNG-O-JET KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 9 May 1980

  • Application: ANDA086578
  • Marketing authorisation holder: ACTAVIS MID ATLANTIC
  • Local brand name: LIDOCAINE HYDROCHLORIDE VISCOUS
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA — authorised 19 December 1980

  • Application: NDA018388
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 2 February 1982

  • Application: ANDA086389
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: LIDOCAINE HYDROCHLORIDE VISCOUS
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA — authorised 9 August 1982

  • Application: ANDA083135
  • Marketing authorisation holder: GD SEARLE LLC
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 18 November 1982

  • Application: ANDA087872
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA — authorised 18 November 1982

  • Application: ANDA087881
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 2 February 1983

  • Application: ANDA087980
  • Marketing authorisation holder: ABBOTT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 10 June 1983

  • Application: ANDA087931
  • Marketing authorisation holder: KENDALL IL
  • Local brand name: LARYNGOTRACHEAL ANESTHESIA KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 17 August 1983

  • Application: ANDA084727
  • Marketing authorisation holder: PHARMATON
  • Local brand name: LIDOCATON
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 16 May 1984

  • Application: ANDA088294
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 May 1984

  • Application: ANDA088330
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 May 1984

  • Application: ANDA088328
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 May 1984

  • Application: ANDA088329
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 17 May 1984

  • Application: ANDA088331
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 31 July 1984

  • Application: ANDA088572
  • Marketing authorisation holder: ABBOTT
  • Local brand name: PEDIATRIC LTA KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 31 July 1984

  • Application: ANDA088542
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LTA II KIT
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

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

Read official source →

FDA — authorised 24 July 1985

  • Application: ANDA088586
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 25 May 1988

  • Application: ANDA089362
  • Marketing authorisation holder: ABBOTT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 30 June 1989

  • Application: ANDA089688
  • Marketing authorisation holder: PACO
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 8 April 1992

  • Application: NDA019830
  • Marketing authorisation holder: B BRAUN
  • Local brand name: LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 29 April 1993

  • Application: ANDA081318
  • Marketing authorisation holder: COSETTE
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: JELLY — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 23 June 1995

  • Application: ANDA040013
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 23 June 1995

  • Application: ANDA040078
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 10 July 1995

  • Application: ANDA040014
  • Marketing authorisation holder: HIKMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

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

Read official source →

FDA — authorised 12 February 2003

  • Application: ANDA040433
  • Marketing authorisation holder: SENTISS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: JELLY — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 27 February 2007

  • Application: ANDA040708
  • Marketing authorisation holder: CHARTWELL MOLECULAR
  • Local brand name: LIDOCAINE HYDROCHLORIDE VISCOUS
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA — authorised 27 February 2007

  • Application: ANDA040710
  • Marketing authorisation holder: LANNETT CO INC
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 23 March 2011

  • Application: ANDA040837
  • Marketing authorisation holder: WATSON LABS INC
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: JELLY — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 12 March 2014

  • Application: ANDA204494
  • Marketing authorisation holder: PAI HOLDINGS PHARM
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 11 April 2014

  • Application: ANDA202242
  • Marketing authorisation holder: RISING
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 28 April 2014

  • Application: ANDA201094
  • Marketing authorisation holder: SAGENT PHARMS INC
  • Local brand name: GLYDO
  • Indication: JELLY — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 14 August 2015

  • Application: ANDA091564
  • Marketing authorisation holder: AM REGENT
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 30 October 2017

  • Application: ANDA207182
  • Marketing authorisation holder: EUGIA PHARMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 18 April 2018

  • Application: ANDA208017
  • Marketing authorisation holder: SPECTRA MDCL DEVICES
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 3 August 2018

  • Application: ANDA208474
  • Marketing authorisation holder: B BRAUN MEDICAL
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 7 May 2020

  • Application: ANDA212821
  • Marketing authorisation holder: HUONS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 8 November 2021

  • Application: ANDA214336
  • Marketing authorisation holder: ASPIRO
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 8 November 2021

  • Application: ANDA214339
  • Marketing authorisation holder: ASPIRO
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 23 March 2022

  • Application: ANDA216250
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 9 June 2022

  • Application: ANDA215132
  • Marketing authorisation holder: AFAXYS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 16 June 2023

  • Application: ANDA217692
  • Marketing authorisation holder: MANKIND PHARMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 11 July 2023

  • Application: ANDA217693
  • Marketing authorisation holder: MANKIND PHARMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 7 December 2023

  • Application: ANDA218182
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 29 April 2024

  • Application: ANDA218411
  • Marketing authorisation holder: THE J MOLNER
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 2 April 2025

  • Application: ANDA219535
  • Marketing authorisation holder: ANTHEA PHARMA
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 29 July 2025

  • Application: ANDA219759
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA — authorised 19 March 2026

  • Application: ANDA220071
  • Marketing authorisation holder: VIWIT PHARM
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA — authorised 20 March 2026

  • Application: ANDA218676
  • Marketing authorisation holder: QUAGEN
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA080414
  • Marketing authorisation holder: MILES
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA

  • Application: ANDA083627
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA

  • Status: approved

FDA

  • Application: NDA018543
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: LIDOCAINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

Lidocaine post-embolization 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 post-embolization approved in United States?

Yes. FDA authorised it on 2 September 1954; FDA authorised it on 11 March 1958; FDA authorised it on 7 May 1959.

Who is the marketing authorisation holder for Lidocaine post-embolization in United States?

FRESENIUS KABI USA holds the US marketing authorisation.