FDA — authorised 28 December 2015
- Application: ANDA204125
- Marketing authorisation holder: XELLIA PHARMS APS
- Status: approved
🇺🇸 Vancocin in United States
FDA authorised Vancocin on 28 December 2015
Marketing authorisations
FDA — authorised 10 July 2018
- Application: NDA209481
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 19 August 2020
- Application: ANDA205694
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 20 September 2021
- Application: ANDA204107
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 12 November 2021
- Application: ANDA201048
- Marketing authorisation holder: PLANO PHARMS
- Indication: Labeling
- Status: approved
Vancocin 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 Vancocin approved in United States?
Yes. FDA authorised it on 28 December 2015; FDA authorised it on 10 July 2018; FDA authorised it on 19 August 2020.
Who is the marketing authorisation holder for Vancocin in United States?
XELLIA PHARMS APS holds the US marketing authorisation.