FDA — authorised 6 November 1964
- Application: ANDA060180
- Marketing authorisation holder: STERISCIENCE
- Local brand name: VANCOCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Administration of Vancomycin in United States
FDA authorised Administration of Vancomycin on 6 November 1964
Marketing authorisations
FDA — authorised 13 July 1983
- Application: ANDA061667
- Marketing authorisation holder: ANI PHARMS
- Local brand name: VANCOCIN HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 21 March 1986
- Application: ANDA062476
- Marketing authorisation holder: STERISCIENCE
- Local brand name: VANCOCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 1986
- Application: NDA050606
- Marketing authorisation holder: ANI PHARMS
- Local brand name: VANCOCIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 July 1986
- Application: ANDA062682
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOLED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 1987
- Application: ANDA062716
- Marketing authorisation holder: STERISCIENCE
- Local brand name: VANCOCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 1987
- Application: ANDA062663
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 1988
- Application: ANDA062879
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 1988
- Application: ANDA062911
- Marketing authorisation holder: HOSPIRA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 1988
- Application: ANDA062912
- Marketing authorisation holder: HOSPIRA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 1990
- Application: ANDA063076
- Marketing authorisation holder: HOSPIRA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 1992
- Application: ANDA062933
- Marketing authorisation holder: HOSPIRA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 1992
- Application: ANDA062931
- Marketing authorisation holder: HOSPIRA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 1993
- Application: NDA050671
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 October 1993
- Application: ANDA063321
- Marketing authorisation holder: LEDERLE
- Local brand name: VANCOLED
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA065401
- Marketing authorisation holder: EUROFARMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 December 2008
- Application: ANDA065397
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 December 2008
- Application: ANDA065432
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 April 2010
- Application: ANDA090250
- Marketing authorisation holder: PLANO PHARMS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 2011
- Application: ANDA091469
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 2011
- Application: ANDA091554
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 April 2012
- Application: ANDA065510
- Marketing authorisation holder: WATSON LABS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 August 2012
- Application: ANDA200837
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 August 2012
- Application: ANDA201048
- Marketing authorisation holder: PLANO PHARMS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 October 2013
- Application: ANDA202464
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 2013
- Application: ANDA202274
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 2013
- Application: ANDA202275
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 January 2015
- Application: ANDA090439
- Marketing authorisation holder: LUPIN
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA201250
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA201251
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA206243
- Marketing authorisation holder: XELLIA PHARMS APS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2015
- Application: ANDA204125
- Marketing authorisation holder: XELLIA PHARMS APS
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2015
- Application: ANDA204107
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 January 2016
- Application: ANDA091532
- Marketing authorisation holder: SAMSON MEDCL
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 21 January 2016
- Application: ANDA205694
- Marketing authorisation holder: GLAND
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2016
- Application: ANDA205779
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2016
- Application: ANDA205780
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 2018
- Application: NDA208910
- Marketing authorisation holder: AZURITY
- Local brand name: FIRVANQ KIT
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 10 July 2018
- Application: NDA209481
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 15 October 2018
- Application: ANDA204360
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2019
- Application: ANDA210729
- Marketing authorisation holder: ORIENT PHARMA CO LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 August 2020
- Application: ANDA203300
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 November 2021
- Application: ANDA215821
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 July 2022
- Application: ANDA216591
- Marketing authorisation holder: ASPIRO
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 July 2022
- Application: ANDA215196
- Marketing authorisation holder: MEITHEAL
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 2022
- Application: ANDA215197
- Marketing authorisation holder: MEITHEAL
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 2022
- Application: ANDA215195
- Marketing authorisation holder: MEITHEAL
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 November 2022
- Application: ANDA214913
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 20 January 2023
- Application: NDA210274
- Marketing authorisation holder: ZHEJIANG NOVUS PHARM
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS, ORAL
- Status: approved
FDA — authorised 23 June 2023
- Application: ANDA215338
- Marketing authorisation holder: AMNEAL
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 29 June 2023
- Application: ANDA217489
- Marketing authorisation holder: HIKMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 4 August 2023
- Application: ANDA217401
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 2 October 2025
- Application: ANDA215324
- Marketing authorisation holder: STERISCIENCE
- Local brand name: VANCOMYCIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA062845
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: VANCOMYCIN HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA062956
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: VANCOR
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is Administration of Vancomycin approved in United States?
Yes. FDA authorised it on 6 November 1964; FDA authorised it on 13 July 1983; FDA authorised it on 21 March 1986.
Who is the marketing authorisation holder for Administration of Vancomycin in United States?
STERISCIENCE holds the US marketing authorisation.