FDA — authorised 18 April 2000
- Application: NDA021130
- Marketing authorisation holder: PFIZER
- Status: supplemented
🇺🇸 LINEZOLID in United States
FDA authorised LINEZOLID on 18 April 2000 · 12,514 US adverse-event reports
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: ANDA205517
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LINEZOLID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA204239
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 21 December 2015
- Application: ANDA078845
- Marketing authorisation holder: RISING
- 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 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
- Indication: Labeling
- 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
- Indication: Labeling
- 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 7 July 2017
- Application: ANDA207001
- Marketing authorisation holder: HQ SPCLT PHARMA
- Status: supplemented
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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 12,514
Most-reported reactions
- Off Label Use — 2,192 reports (17.52%)
- Drug Ineffective — 1,782 reports (14.24%)
- Thrombocytopenia — 1,695 reports (13.54%)
- Anaemia — 1,389 reports (11.1%)
- Drug Interaction — 1,170 reports (9.35%)
- Nausea — 955 reports (7.63%)
- Lactic Acidosis — 859 reports (6.86%)
- Vomiting — 836 reports (6.68%)
- Acute Kidney Injury — 832 reports (6.65%)
- Pyrexia — 804 reports (6.42%)
LINEZOLID 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 LINEZOLID approved in United States?
Yes. FDA authorised it on 18 April 2000; FDA authorised it on 18 May 2015; FDA authorised it on 3 June 2015.
Who is the marketing authorisation holder for LINEZOLID in United States?
PFIZER holds the US marketing authorisation.