FDA — authorised 30 October 1981
- Application: NDA018517
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Bismuth quadruple therapy in United States
FDA authorised Bismuth quadruple therapy on 30 October 1981
Marketing authorisations
FDA — authorised 24 December 1981
- Application: NDA018657
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: FLAGYL I.V. RTU IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 1982
- Application: NDA018620
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 1982
- Application: NDA018764
- Marketing authorisation holder: WATSON LABS
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 1982
- Application: NDA018740
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 1983
- Application: NDA018818
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1983
- Application: NDA018871
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: PROTOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 1983
- Application: NDA018930
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 1983
- Application: NDA018845
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 1983
- Application: NDA018889
- Marketing authorisation holder: ABBOTT
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 1984
- Application: NDA018907
- Marketing authorisation holder: HIKMA
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 April 1984
- Application: NDA019029
- Marketing authorisation holder: LNK
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 1984
- Application: ANDA070027
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 1984
- Application: ANDA070033
- Marketing authorisation holder: PLIVA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 1984
- Application: ANDA070008
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 1984
- Application: ANDA070009
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1984
- Application: ANDA070035
- Marketing authorisation holder: WATSON LABS
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 1985
- Application: ANDA070040
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 1985
- Application: ANDA070039
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1985
- Application: ANDA070044
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 1986
- Application: ANDA070772
- Marketing authorisation holder: INNOGENIX
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 1995
- Application: NDA020531
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: METROCREAM
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 October 1996
- Application: ANDA074523
- Marketing authorisation holder: LABS AF
- Local brand name: METROMIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1997
- Application: NDA020868
- Marketing authorisation holder: PFIZER
- Local brand name: FLAGYL ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 November 1998
- Application: NDA020901
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: METROLOTION
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 25 June 2003
- Application: ANDA076462
- Marketing authorisation holder: ABLE
- Local brand name: METRONIDAZOLE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 June 2003
- Application: ANDA076519
- Marketing authorisation holder: ABLE
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2003
- Application: ANDA076505
- Marketing authorisation holder: ABLE
- Local brand name: METRONIDAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 2004
- Application: ANDA076522
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METRONIDAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 May 2004
- Application: ANDA076408
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: METRONIDAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 May 2006
- Application: ANDA077197
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: METRONIDAZOLE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 13 July 2006
- Application: ANDA077547
- Marketing authorisation holder: ENCUBE
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 18 July 2006
- Application: ANDA077819
- Marketing authorisation holder: TARO
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 October 2006
- Application: ANDA077264
- Marketing authorisation holder: ENCUBE
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 19 December 2007
- Application: ANDA077549
- Marketing authorisation holder: COSETTE
- Local brand name: METRONIDAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 March 2008
- Application: ANDA078084
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: METRONIDAZOLE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 2009
- Application: ANDA079067
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2009
- Application: ANDA079065
- Marketing authorisation holder: ALEMBIC
- Local brand name: METRONIDAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 May 2010
- Application: ANDA090222
- Marketing authorisation holder: ALEMBIC
- Local brand name: METRONIDAZOLE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 July 2011
- Application: ANDA090903
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 22 January 2014
- Application: ANDA203458
- Marketing authorisation holder: UNICHEM
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2014
- Application: NDA205223
- Marketing authorisation holder: CHEMO RESEARCH SL
- Local brand name: NUVESSA
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 29 May 2015
- Application: ANDA203974
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 2015
- Application: ANDA205245
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2016
- Application: ANDA207309
- Marketing authorisation holder: FLAMINGO PHARMS
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2016
- Application: ANDA206560
- Marketing authorisation holder: CADILA
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 2017
- Application: ANDA205531
- Marketing authorisation holder: RISING
- Local brand name: METRONIDAZOLE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2017
- Application: ANDA208681
- Marketing authorisation holder: ALEMBIC
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2017
- Application: ANDA209096
- Marketing authorisation holder: LUPIN
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 2017
- Application: ANDA209794
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2019
- Application: ANDA211786
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 3 August 2020
- Application: ANDA212435
- Marketing authorisation holder: GLAND
- Local brand name: METRONIDAZOLE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 October 2021
- Application: ANDA213648
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA215794
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 23 January 2023
- Application: ANDA216692
- Marketing authorisation holder: COSETTE
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 21 April 2023
- Application: ANDA217128
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: METRONIDAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 June 2023
- Application: ANDA215610
- Marketing authorisation holder: ENCUBE
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 12 July 2023
- Application: ANDA216323
- Marketing authorisation holder: COSETTE
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 22 September 2023
- Application: NDA216755
- Marketing authorisation holder: SAPTALIS PHARMS
- Local brand name: LIKMEZ
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 October 2024
- Application: ANDA218941
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 December 2024
- Application: ANDA216750
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: METRONIDAZOLE
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 9 July 2025
- Application: ANDA219295
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: METRONIDAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 February 2026
- Application: ANDA220095
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: METRONIDAZOLE
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA070071
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070042
- Marketing authorisation holder: WATSON LABS
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018599
- Marketing authorisation holder: WATSON LABS
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070021
- Marketing authorisation holder: HALSEY
- Local brand name: METRONIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070029
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: SATRIC
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070004
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070170
- Marketing authorisation holder: WATSON LABS
- Local brand name: METRONIDAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070731
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: SATRIC
- Indication: TABLET — ORAL
- Status: approved
Bismuth quadruple therapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Bismuth quadruple therapy approved in United States?
Yes. FDA authorised it on 30 October 1981; FDA authorised it on 24 December 1981; FDA authorised it on 4 March 1982.
Who is the marketing authorisation holder for Bismuth quadruple therapy in United States?
IVAX SUB TEVA PHARMS holds the US marketing authorisation.