Is Levofloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 54 valid registrations of Levofloxacin, including ADVAQUIN 500MG FILM COATED TABLET (500 mg, Film-coated tablet, SAR 40.40); Bonlevo (5 mg/ml, Intravenous infusion, SAR 71.30); EMIFLOC 500 mg Film-coated Tablet (500 mg, Film-coated tablet, SAR 41.75); ERADOCIN (500 mg, Film-coated tablet, SAR 40.40); EVOX 250MG FILM COATED TABLET (250 mg, Film-coated tablet, SAR 23.80).

Is Levofloxacin approved by the US FDA?

Drugs@FDA lists 49 application product lines for Levofloxacin, including LEVOFLOXACIN (Prescription); LEVOFLOXACIN (Prescription); LEVOFLOXACIN (Prescription); LEVOFLOXACIN (Prescription); LEVOFLOXACIN (Prescription).

Is Levofloxacin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Levofloxacin: Quinsair.

Is Levofloxacin on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Multi-drug resistant Mycobacterium tuberculosis.

Are there safety signals or safety updates for Levofloxacin?

EMA PRAC: 5 entries; US FDA: 3 entries; MHRA: 1 entry (latest 2021-09-02).

Active substance

Levofloxacin

SFDA 62
US FDA 49
EMA 1
Health Canada 16
US price lines 5
NHS prices 6
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADVAQUIN 500MG FILM COATED TABLET	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	OMAN PHARMACEUTICAL PRODUCTS	Valid
Bonlevo	5 mg/ml	Intravenous infusion · Intravenous use	1 Bottle	SAR 71.30	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
EMIFLOC 500 mg Film-coated Tablet	500 mg	Film-coated tablet · Oral use	7 Blister	SAR 41.75	Generic · Prescription	GLOBAL PHARMA	Valid
EMIFLOC 500 mg Film-coated Tablet	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 29.80	Generic · Prescription	GLOBAL PHARMA	Valid
ERADOCIN	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
EVOX 250MG FILM COATED TABLET	250 mg	Film-coated tablet · Oral use	7 Blister	SAR 23.80	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
EVOX 500MG FILM COATED TABLET	500 mg	Film-coated tablet · Oral use	7 Blister	SAR 35.25	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
EVOX 750MG FILM COATED TABLET	750 mg	Film-coated tablet · Oral use	7 Blister	SAR 60.80	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
Eradocin	750 mg	Film-coated tablet · Oral use	5 Blister	SAR 47.20	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Evox	500 mg	Film-coated tablet · Oral use	14 Blister	SAR 64.25	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
FLOXMED 500MG F.C.TABLET	500 mg	Film-coated tablet · Oral use	7 Blister	SAR 56.55	Generic · Prescription	Med City Pharma	Valid
Floxmed	750 mg	Film-coated tablet · Oral use	7 Bottle	SAR 66.10	Generic · Prescription	Med City Pharma	Valid
LAVOXIN 500 mg solution for infusion	5 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 79.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LEVACIN 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
LEVACIN 750 mg film-coated tablet	750 mg	Film-coated tablet · Oral use	5 Blister	SAR 64.75	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
LEVAQUIN 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
LEVOACT	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 29.80	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEVOACT	500 mg	Film-coated tablet · Oral use	7 Blister	SAR 41.75	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEVOACT	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 59.65	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEVOBAT 500 MG FILM COATED TABLET	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
LEVODIS 5 mg/ml Solution For Injection	5 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 54.15	Generic · Prescription	LES LABORATOIRES MEDIS	Valid
LEVOFLOX 500MG F.C. TABLET	500 mg	Tablet · Oral use	5 Blister	SAR 49.90	Generic · Prescription	National Pharmaceutical Industries Co. (SAOG)	Valid
LEVOFLOXACIN Sandoz 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 31.55	Generic · Prescription	SANDOZ	Valid
LEVON 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	5 Blister	SAR 40.40	Generic · Prescription	DAMMAM PHARMA	Valid
LEVON 750 mg film-coated tablet	750 mg	Film-coated tablet · Oral use	5 Blister	SAR 58.25	Generic · Prescription	DAMMAM PHARMA	Valid

37 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); ACUTE PYELONEPHRITIS; ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- ENTEROPATHOGENIC ESCHERICHIA COLI; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; BARIATRIC SURGERY; DENTAL ABSCESS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; HUMAN IMMUNODEFICIENCY VIRUS; INTRA-ABDOMINAL INFECTIONS; LOWER URINARY TRACT INFECTIONS; MUCOPURULENT CONJUCTIVITIS - CHLAMYDIAL CONJUNCTIVITIS; ORCHITIS AND EPIDIDYMITIS; OSTEOMYELITIS; OTITIS MEDIA; PERITONITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); RENAL TRANSPLANT; SINUSITIS; TRAVEL RELATED INFECTIONS-TREATMENT; TUBERCULOSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
LEVOFLOXACIN	0.5%	solution/drops · ophthalmic	RISING	Prescription	20 Dec 2010
LEVOFLOXACIN	0.5%	solution/drops · ophthalmic	RUBICON RESEARCH	Prescription	20 Dec 2010
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	TEVA	Prescription	20 Jun 2011
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	DR REDDYS LABS INC	Prescription	20 Jun 2011
LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML); EQ 750MG/30ML (EQ 25MG/ML)	injectable · injection	RISING	Prescription	20 Jun 2011
LEVOFLOXACIN	250MG/10ML	solution · oral	NOVITIUM PHARMA	Prescription	20 Jun 2011
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	20 Jun 2011
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	20 Jun 2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML); EQ 500MG/100ML (EQ 5MG/ML); EQ 750MG/150ML (EQ 5MG/ML)	injectable · injection	INFORLIFE	Prescription	7 Jul 2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML); EQ 500MG/100ML (EQ 5MG/ML); EQ 750MG/150ML (EQ 5MG/ML)	injectable · injection	HIKMA FARMACEUTICA	Prescription	16 Sep 2011
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	ORBION PHARMS	Prescription	30 Jan 2012
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	22 Mar 2012
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	CHARTWELL MOLECULAR	Prescription	30 Mar 2012
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	7 Sep 2012
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML); EQ 500MG/100ML (EQ 5MG/ML); EQ 750MG/150ML (EQ 5MG/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	19 Jun 2013
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	HETERO LABS LTD V	Prescription	8 Jan 2015
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML); EQ 500MG/100ML (EQ 5MG/ML); EQ 750MG/150ML (EQ 5MG/ML)	injectable · injection	HOSPIRA	Prescription	3 Sep 2015
LEVOFLOXACIN	250MG/10ML	solution · oral	LANNETT CO INC	Prescription	25 May 2018
LEVOFLOXACIN	250MG; 500MG; 750MG	tablet · oral	HEC PHARM	Prescription	5 Feb 2019
LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML); EQ 750MG/30ML (EQ 25MG/ML)	injectable · injection	GLAND	Prescription	22 Apr 2020
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML); EQ 500MG/100ML (EQ 5MG/ML); EQ 750MG/150ML (EQ 5MG/ML)	injectable · injection	GLAND	Prescription	30 Dec 2020
LEVAQUIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	JANSSEN PHARMS	Discontinued	20 Dec 1996
LEVAQUIN	EQ 500MG/20ML (EQ 25MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 750MG/30ML (EQ 25MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	JANSSEN PHARMS	Discontinued	20 Dec 1996
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 500MG/100ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 750MG/150ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	JANSSEN PHARMS	Discontinued	20 Dec 1996
QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution/drops · ophthalmic	SANTEN	Discontinued	18 Aug 2000

24 more — full table

EMA European Union — centrally authorised medicines

Quinsair Chiesi Farmaceutici S.p.A · Authorised · authorised 25 Mar 2015 · ATC J01MA12

Therapeutic indication (EMA)

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-LEVOFLOXACIN	02284707	250 MG	TABLET · ORAL	APOTEX INC
APO-LEVOFLOXACIN	02284715	500 MG	TABLET · ORAL	APOTEX INC
APO-LEVOFLOXACIN	02325942	750 MG	TABLET · ORAL	APOTEX INC
JAMP LEVOFLOXACIN	02508443	250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVOFLOXACIN	02508451	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVOFLOXACIN	02508478	750 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
LEVOFLOXACIN IN 5% DEXTROSE INJECTION	02314932	5 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
LEVOFLOXACIN IN 5% DEXTROSE INJECTION	02537079	5 MG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED
PRO-LEVOFLOXACIN	02415879	500 MG	TABLET · ORAL	PRO DOC LIMITEE
QUINSAIR	02442302	240 MG / 2.4 ML	SOLUTION · INHALATION	CHIESI FARMACEUTICI S.P.A.
SANDOZ LEVOFLOXACIN	02298635	250 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ LEVOFLOXACIN	02298643	500 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ LEVOFLOXACIN	02298651	750 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-LEVOFLOXACIN	02315424	250 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-LEVOFLOXACIN	02315432	500 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-LEVOFLOXACIN	02315440	750 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LEVOFLOXACIN 25 MG/ML SOLUTION	$1.47062	per ML	23 Sep 2026
US NADAC	LEVOFLOXACIN 25 MG/ML SOLUTION	$1.78878	per ML	23 Sep 2026
US NADAC	LEVOFLOXACIN 250 MG TABLET	$0.1086	per EA	23 Sep 2026
US NADAC	LEVOFLOXACIN 500 MG TABLET	$0.13317	per EA	23 Sep 2026
US NADAC	LEVOFLOXACIN 750 MG TABLET	$0.25858	per EA	23 Sep 2026
NHS Drug Tariff	Levofloxacin 250mg tablets	£11.09	10 tablet	1 Oct 2026
NHS Drug Tariff	Levofloxacin 500mg tablets	£5.09	5 tablet	1 Oct 2026
NHS Drug Tariff	Levofloxacin 500mg tablets	£10.18	10 tablet	1 Oct 2026
NHS Drug Tariff	Levofloxacin 5mg/ml eye drops	£9.52	5 ml	1 Oct 2026
NHS Drug Tariff	Levofloxacin 5mg/ml eye drops 0.3ml unit dose preservative free	£17.95	30 unit dose	1 Oct 2026
NHS Drug Tariff	Levofloxacin 5mg/ml eye drops preservative free	£13.46	5 ml	1 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)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > dispersible tablet: 100 mg (EMLc) | Oral > Solid > tablet: 250 mg; 500 mg; 750 mg (EML)

Safety signals and safety-related labeling changes

EMA PRAC 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes
US FDA 22 Jun 2020 LEVAQUIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
Action for MAH: update of the product information: No
US FDA 8 Feb 2017 LEVAQUIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Feb 2017 LEVAQUIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Levofloxacin: some indications restricted
Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.

All safety entries for levofloxacin →

Combinations containing Levofloxacin

Dexamethasone + levofloxacin

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.