Is Norfloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Norfloxacin, including APIFLOX 0.3% EYE DROPS (0.3 %, Eye drops, SAR 13.85); UROXIN 400MG TAB (400 mg, Film-coated tablet, SAR 41.50).

Is Norfloxacin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Norfloxacin, including NOROXIN (Discontinued); CHIBROXIN (Discontinued).

Are there safety signals or safety updates for Norfloxacin?

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

Active substance

Norfloxacin

SFDA 5
US FDA 2
Health Canada 1
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
APIFLOX 0.3% EYE DROPS	0.3 %	Eye drops · Ophthalmic use	1 Dropper Container	SAR 13.85	NCE · Prescription	Amman Pharmaceutical Industries (API)	Valid
UROXIN 400MG TAB	400 mg	Film-coated tablet · Oral use	14 Blister	SAR 41.50	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
NOROXIN 400MG TABLETS	400 mg	Tablet · Oral use	14 Blister	SAR 23.65	Generic · Prescription	Algorithm SAL	Suspended
NORACIN 400MG TAB	400 mg	Tablet · Oral use	14 Blister	SAR 22.20	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
NOROXIN 400MG TAB	400 mg	Tablet · Oral use	14 Blister	SAR 50.00	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE - CHLAMYDIAL CONJUNCTIVITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
NOROXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	MERCK	Discontinued	31 Oct 1986
CHIBROXIN	0.3%	solution/drops · ophthalmic	MERCK	Discontinued	17 Jun 1991

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NORFLOXACIN	02229524	400 MG	TABLET · ORAL	AA PHARMA INC

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
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 26 Jul 2016 NOROXIN — 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 Norfloxacin: restricted use in urinary infections
The European Medicines Agency (EMA) has concluded that oral fluoroquinolone norfloxacin (Utinor) shouldn't be used to treat acute or chronic, complicated pyelonephritis.

All safety entries for norfloxacin →

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.