Regulatory PathRegulatory requirements compared

Active substance

Linezolid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DILIZOLEN 600MG TABLET600 mgTablet · Oral use20 BlisterSAR 1404.45Generic · PrescriptionGlenmark Pharmaceuticals LimitedValid
KINZADO600 mgFilm-coated tablet · Oral use10 BlisterSAR 1447.20Generic · PrescriptionSPIMACO ADDWAEIHValid
LINDEC 600 mg Film-coated Tablet600 mgFilm-coated tablet · Oral use30 BottleSAR 1535.75Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
LINID 2 MG/ML SOLUTION FOR INFUSION2 mg/mlSolution for infusion · Intravenous use1 BagSAR 144.15Generic · PrescriptionAJA PHARMACEUTICAL INDUSTRIESValid
Lenzal600 mgFilm-coated tablet · Oral use30 BlisterSAR 1877.10Generic · PrescriptionAlrai Pharmaceutical industry Co. (L.L.C)Valid
Lidolinz600 mgFilm-coated tablet · Oral use10 BlisterSAR 625.65Generic · PrescriptionCALIFORNIA GREENS CORPORATION FACTORYValid
ZERSA 600 mg Film-coated Tablet600 mgFilm-coated tablet · Oral use10 BlisterSAR 1929.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
ZYVOX 2 MG/ML SOLUTION FOR INFUSION2 mg/mlSolution for infusion · Intravenous use10 BagSAR 1601.75NCE · PrescriptionPFIZER INCValid
Zenix600 mgFilm-coated tablet · Oral use20 BlisterSAR 1137.60Generic · PrescriptionSTADA ARZNEIMITTEL GmbHValid
Zersa20 mg/mlOral suspension · Oral use1 BottleSAR 630.00NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Zersa2 mg/mlSolution for infusion · Intravenous use1 BagSAR 136.90Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Zextro600 mgFilm-coated tablet · Oral use20 BottleSAR 2894.40Generic · PrescriptionMed City PharmaValid
Zillion600 mgFilm-coated tablet · Oral use10 BlisterSAR 1447.20Generic · PrescriptionSaudi AmaroxValid
Zillion20 mg/mlOral suspension · Oral use1 BottleSAR 598.50Generic · PrescriptionSaudi AmaroxValid
Zodinex600 mgFilm-coated tablet · Oral use20 BlisterSAR 1251.35Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; Pyogenic Arthritis; TRAVEL RELATED INFECTIONS-TREATMENT; TUBERCULOSIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ZYVOX200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousPFIZERPrescription18 Apr 2000
ZYVOX100MG/5MLfor suspension · oralPFIZERPrescription18 Apr 2000
LINEZOLID100MG/5MLfor suspension · oralHIKMA PHARMSPrescription3 Jun 2015
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER600MG/300ML (2MG/ML)solution · intravenousHOSPIRAPrescription18 Jun 2015
LINEZOLID200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousSANDOZPrescription16 Jul 2015
LINEZOLID600MGtablet · oralRISINGPrescription21 Dec 2015
LINEZOLID600MGtablet · oralGLENMARK SPECLTPrescription21 Dec 2015
LINEZOLID600MGtablet · oralHETERO LABS LTD VPrescription21 Dec 2015
LINEZOLID600MGtablet · oralALEMBICPrescription21 Dec 2015
LINEZOLID600MGtablet · oralALKEM LABS LTDPrescription21 Dec 2015
LINEZOLID600MG/300ML (2MG/ML)solution · intravenousFRESENIUS KABI USAPrescription15 Mar 2016
LINEZOLID600MG/300ML (2MG/ML)solution · intravenousEUGIA PHARMAPrescription4 Aug 2016
LINEZOLID600MGtablet · oralNOVEL LABS INCPrescription22 Aug 2016
LINEZOLID200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousNANG KUANG PHARM COPrescription20 Dec 2016
LINEZOLID600MGtablet · oralZYDUS PHARMSPrescription22 Feb 2017
LINEZOLID200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousSAGENT PHARMS INCPrescription2 Mar 2017
LINEZOLID200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousHQ SPCLT PHARMAPrescription7 Jul 2017
LINEZOLID200MG/100ML (2MG/ML); 600MG/300ML (2MG/ML)solution · intravenousSTERISCIENCEPrescription6 Dec 2017
LINEZOLID600MGtablet · oralCHARTWELL RXPrescription25 Apr 2019
LINEZOLID600MG/300ML (2MG/ML)solution · intravenousHIKMA PHARMSPrescription22 Aug 2022
LINEZOLID100MG/5MLfor suspension · oralHETERO LABSPrescription31 Oct 2022
LINEZOLID600MGtablet · oralMACLEODS PHARMSPrescription10 Oct 2024
LINEZOLID600MG/300ML (2MG/ML)solution · intravenousCAPLINPrescription8 Dec 2025
ZYVOX400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 600MGtablet · oralPFIZERDiscontinued18 Apr 2000
ZYVOX400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intravenousPFIZERDiscontinued18 Apr 2000

5 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-LINEZOLID02426552600 MGTABLET · ORALAPOTEX INC
JAMP LINEZOLID02520354600 MGTABLET · ORALJAMP PHARMA CORPORATION
LINEZOLID INJECTION024308272 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
LINEZOLID INJECTION024812782 MG / MLSOLUTION · INTRAVENOUSJAMP PHARMA CORPORATION
LINEZOLID INJECTION025397482 MG / MLSOLUTION · INTRAVENOUSEUGIA PHARMA INC.
SANDOZ LINEZOLID02422689600 MGTABLET · ORALSANDOZ CANADA INCORPORATED
ZYVOXAM022436852 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
ZYVOXAM02243686100 MG / 5 MLPOWDER FOR SUSPENSION · ORALPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLINEZOLID 100 MG/5 ML SUSP$2.73583per ML23 Sep 2026
US NADACLINEZOLID 600 MG TABLET$1.44111per EA23 Sep 2026
NHS Drug TariffLinezolid 100mg/5ml oral suspension£222.50150 ml1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.3. Reserve group antibiotics · complementary
    Methicillin resistant Staphylococcus aureus; Vancomycin resistant Staphylococcus aureus; Vancomycin resistant Enterococcus
    Parenteral > General injections > IV: 2 mg per mL in 300 mL bag | Oral > Liquid: 100 mg per 5 mL powder for oral liquid | Oral > Solid > dispersible tablet: 150 mg (EMLc) | Oral > Solid > tablet: 600 mg (EML)
  • 6.2.5. Antituberculosis medicines · core
    Multi-drug resistant Mycobacterium tuberculosis
    Oral > Solid > dispersible tablet: 150 mg (scored) (EMLc) | Oral > Solid > tablet: 600 mg

Safety signals and safety-related labeling changes

  • US FDA 9 Jun 2026 ZYVOX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Jun 2026 ZYVOX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Jun 2026 ZYVOX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • MHRA 11 Dec 2014 Linezolid: restricted indication
    Linezolid is not active against infections caused by Gram-negative pathogens, and treatment should be started only after specialist microbiological advice.

All safety entries for linezolid →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.