FDA — authorised 9 February 1976
- Application: ANDA061926
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 levofloxacin-based triple therapy for 10 days in United States
FDA authorised levofloxacin-based triple therapy for 10 days on 9 February 1976
Marketing authorisations
FDA — authorised 3 August 1978
- Application: ANDA062058
- Marketing authorisation holder: CHARTWELL
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 December 1978
- Application: ANDA062059
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 November 1979
- Application: ANDA062226
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: LAROTID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 December 1981
- Application: ANDA062323
- Marketing authorisation holder: APOTHECON
- Local brand name: POLYMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 December 1982
- Application: ANDA061931
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 August 1984
- Application: NDA050564
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '500'
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 1984
- Application: NDA050575
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '125'
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 July 1985
- Application: NDA050597
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '125'
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 7 August 1985
- Application: ANDA062528
- Marketing authorisation holder: LABS ATRAL
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1987
- Application: ANDA062853
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1987
- Application: ANDA062854
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 February 1988
- Application: ANDA062881
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 February 1988
- Application: ANDA062884
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 November 1988
- Application: ANDA062946
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 November 1988
- Application: ANDA062927
- Marketing authorisation holder: PH HEALTH
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 January 1989
- Application: ANDA063001
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA063030
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA063031
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1992
- Application: ANDA064013
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 29 January 1996
- Application: ANDA064139
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 13 February 1996
- Application: NDA050720
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '875'
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1996
- Application: NDA050726
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '400'
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 31 May 1996
- Application: NDA050725
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN '200'
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 December 1996
- Application: ANDA064031
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 2 December 1997
- Application: NDA050757
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: PREVPAC (COPACKAGED)
- Indication: CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 8 April 1999
- Application: ANDA065016
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 1999
- Application: ANDA065021
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 18 September 2000
- Application: ANDA065056
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 2000
- Application: ANDA065059
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2000
- Application: ANDA065060
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 14 March 2002
- Application: ANDA065063
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2002
- Application: ANDA065064
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2002
- Application: ANDA065065
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 5 June 2002
- Application: ANDA065066
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 September 2002
- Application: ANDA065102
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2002
- Application: NDA050785
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AUGMENTIN XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 October 2002
- Application: ANDA065096
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2002
- Application: ANDA065101
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2002
- Application: ANDA065109
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2002
- Application: ANDA065093
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2002
- Application: ANDA065117
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2002
- Application: ANDA065113
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 December 2002
- Application: ANDA065119
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 December 2002
- Application: ANDA065098
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 March 2003
- Application: ANDA065132
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 August 2003
- Application: ANDA065080
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: DISPERMOX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 December 2003
- Application: ANDA065161
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 4 December 2003
- Application: ANDA065159
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: DISPERMOX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 March 2004
- Application: ANDA065162
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 May 2004
- Application: ANDA065089
- Marketing authorisation holder: TEVA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 July 2005
- Application: ANDA065228
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2005
- Application: ANDA065256
- Marketing authorisation holder: AUROBINDO
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2005
- Application: ANDA065271
- Marketing authorisation holder: AUROBINDO
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 March 2006
- Application: ANDA065255
- Marketing authorisation holder: HIKMA
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 2006
- Application: ANDA065325
- Marketing authorisation holder: HIKMA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 June 2006
- Application: ANDA065322
- Marketing authorisation holder: HIKMA
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 December 2006
- Application: ANDA065334
- Marketing authorisation holder: AUROBINDO
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 January 2007
- Application: ANDA065324
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 February 2007
- Application: ANDA065291
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA065387
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA065378
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 June 2007
- Application: ANDA065319
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 August 2007
- Application: ANDA065358
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 November 2007
- Application: ANDA065373
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 October 2008
- Application: ANDA065317
- Marketing authorisation holder: APOTEX INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2008
- Application: ANDA065431
- Marketing authorisation holder: CIPLA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA065344
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXICILLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2009
- Application: ANDA065333
- Marketing authorisation holder: APOTEX INC
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2010
- Application: ANDA090227
- Marketing authorisation holder: SANDOZ
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 December 2011
- Application: ANDA201090
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 December 2011
- Application: ANDA201091
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 January 2012
- Application: ANDA091568
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 2012
- Application: ANDA091569
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2013
- Application: ANDA065420
- Marketing authorisation holder: CIPLA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 September 2014
- Application: ANDA204030
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 August 2016
- Application: ANDA203824
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA205707
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA204755
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA209371
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 November 2019
- Application: NDA213004
- Marketing authorisation holder: TALICIA HOLDINGS
- Local brand name: TALICIA
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 June 2020
- Application: ANDA205274
- Marketing authorisation holder: HIKMA
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 21 May 2021
- Application: ANDA205187
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 May 2022
- Application: NDA215153
- Marketing authorisation holder: PHATHOM
- Local brand name: VOQUEZNA DUAL PAK
- Indication: CAPSULE, TABLET — ORAL
- Status: approved
FDA — authorised 24 June 2022
- Application: ANDA207471
- Marketing authorisation holder: MICRO LABS
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 September 2023
- Application: ANDA209351
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA209992
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA209991
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA210374
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 December 2023
- Application: ANDA217805
- Marketing authorisation holder: MICRO LABS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 December 2023
- Application: ANDA210416
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA062067
- Marketing authorisation holder: MYLAN
- Local brand name: AMOXICILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA064131
- Marketing authorisation holder: APOTHECON
- Local brand name: AMOXICILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA
- Application: ANDA062090
- Marketing authorisation holder: MYLAN
- Local brand name: AMOXICILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062107
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: UTIMOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062131
- Marketing authorisation holder: WYETH AYERST
- Local brand name: WYMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062127
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: UTIMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062120
- Marketing authorisation holder: WYETH AYERST
- Local brand name: WYMOX
- Indication: CAPSULE — ORAL
- Status: approved
levofloxacin-based triple therapy for 10 days 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 levofloxacin-based triple therapy for 10 days approved in United States?
Yes. FDA authorised it on 9 February 1976; FDA authorised it on 3 August 1978; FDA authorised it on 8 December 1978.
Who is the marketing authorisation holder for levofloxacin-based triple therapy for 10 days in United States?
TEVA holds the US marketing authorisation.