FDA — authorised 27 June 2012
- Application: ANDA200222
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Zyvox in United States
FDA authorised Zyvox on 27 June 2012
Marketing authorisations
FDA — authorised 18 May 2015
- Application: ANDA078061
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2015
- Application: ANDA200068
- Marketing authorisation holder: HIKMA
- Local brand name: LINEZOLID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 June 2015
- Application: NDA206473
- Marketing authorisation holder: HOSPIRA
- Local brand name: LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 16 July 2015
- Application: ANDA200904
- Marketing authorisation holder: SANDOZ
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA078987
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA205233
- Marketing authorisation holder: ALEMBIC
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA204239
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA204536
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA205517
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA078845
- Marketing authorisation holder: RISING
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2016
- Application: ANDA091210
- Marketing authorisation holder: GATE PHARMS
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2016
- Application: ANDA204764
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 August 2016
- Application: ANDA206917
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2016
- Application: ANDA207526
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2016
- Application: ANDA207354
- Marketing authorisation holder: NANG KUANG PHARM CO
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 February 2017
- Application: ANDA206097
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2017
- Application: ANDA204696
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA205154
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 25 April 2019
- Application: ANDA210702
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA206454
- Marketing authorisation holder: HIKMA
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2022
- Application: ANDA211813
- Marketing authorisation holder: HETERO LABS
- Local brand name: LINEZOLID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 10 October 2024
- Application: ANDA210378
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2025
- Application: ANDA219558
- Marketing authorisation holder: CAPLIN
- Local brand name: LINEZOLID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Zyvox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Zyvox approved in United States?
Yes. FDA authorised it on 27 June 2012; FDA authorised it on 18 May 2015; FDA authorised it on 3 June 2015.
Who is the marketing authorisation holder for Zyvox in United States?
TEVA PHARMS holds the US marketing authorisation.