Norfloxacin

Generic Name: Norfloxacin

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₈FN_₃O_₃

CAS Number: 70458-96-7

Unique Ingredient Identifier: N0F8P22L1P

Overview

A synthetic fluoroquinolone (fluoroquinolones) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA gyrase.

Indication

For the treatment of urinary tract infection

Associated Conditions

Cystitis
Gonococcal cervicitis
Infectious diarrhea
Pyelitis
Pyelonephritis
Spontaneous Bacterial Peritonitis (SBP)
Traveler's Diarrhea
Urethritis gonococcal

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparative Study of Secondary Prophylaxis for SBP	2025/02/14	NCT06827756	Phase 4	Completed	Tanta University
Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial)	2024/01/10	NCT06199843	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis	2021/02/10	NCT04746937	Phase 3	UNKNOWN	Tanta University
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis	2019/11/13	NCT04161768	Phase 3	Recruiting	Tanta University
Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis	2019/11/12	NCT04159870	Phase 3	UNKNOWN	Ospedali Riuniti di Foggia
Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis	2018/10/11	NCT03702426	Not Applicable	Completed	Institute of Liver and Biliary Sciences, India
Noroxin Efficacy and Safety Trial	2018/04/24	NCT03506256	Phase 4	UNKNOWN	OBS Pakistan
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis	2014/04/22	NCT02120196	Phase 3	UNKNOWN	Sherief Abd-Elsalam
Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention	2012/03/02	NCT01542801	Phase 4	Completed	Korea University
Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)	2012/02/06	NCT01527019	Phase 3	Withdrawn	Eurofarma Laboratorios S.A.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LOXONE-400 TABLET 400 mg	MICRO LABS LTD	SIN08998P	TABLET, FILM COATED	400 mg	11/7/1996

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APO-NORFLOXACIN norfloxacin 400 mg tablet bottle	155546	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/19/2008
ROXIN norfloxacin 400 mg tablet blister pack	93210	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/26/2003
CHEMMART NORFLOXACIN norfloxacin 400 mg tablet bottle	155547	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/19/2008
TERRY WHITE CHEMISTS NORFLOXACIN norfloxacin 400 mg tablet bottle	155548	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/19/2008
GENRX NORFLOXACIN norfloxacin 400mg tablet blister pack	80662	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/13/2001
GN-NORFLOXACIN norfloxacin 400mg tablet blister pack	184276	Strides Pharma Science Pty Ltd	Medicine	A	4/20/2012
LAXIFLOCIN norfloxacin 400mg tablet blister pack	184275	Strides Pharma Science Pty Ltd	Medicine	A	4/20/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NOROXIN	Merck Canada Inc	01908294	Solution - Ophthalmic	3 MG / ML	12/31/1990
NORFLOXACIN	aa pharma inc	02229524	Tablet - Oral	400 MG	7/20/1998
NORFLOXACINE-400	PRO DOC LIMITEE	02239670	Tablet - Oral	400 MG / TAB	8/23/1999
RIVA-NORFLOXACIN	laboratoire riva inc.	02301504	Tablet - Oral	400 MG	6/13/2008
NOROXIN	Merck Canada Inc	00643025	Tablet - Oral	400 MG	12/31/1986
RIVA-NORFLOXACIN	laboratoire riva inc.	02241483	Tablet - Oral	400 MG	1/31/2000
NORFLOXACIN	Cobalt Pharmaceuticals Company	02344882	Tablet - Oral	400 MG	N/A
AVA-NORFLOXACIN	avanstra inc	02366304	Tablet - Oral	400 MG	11/23/2011
TEVA-NORFLOXACIN	teva canada limited	02237682	Tablet - Oral	400 MG	8/20/1998
CO NORFLOXACIN	Cobalt Pharmaceuticals Company	02269627	Tablet - Oral	400 MG	7/18/2006

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NORFLOXACINO QUALIGEN 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Neuraxpharm Spain S.L.	56901	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NORFLOXACINO STADA 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	63202	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
NORFLOXACINO CINFA 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	68627	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
NORFLOXACINO NORMON 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	63159	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
NORFLOXACINO PENSA 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Towa Pharmaceutical S.A.	68626	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
NORFLOXACINO LESVI 400 MG COMPRIMIDOS EFG	Laboratorios Lesvi Sl	62309	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NORFLOXACINO SANDOZ 400 mg COMPRIMIDOS EFG	Sandoz Farmaceutica S.A.	62622	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
CHIBROXIN 3 mg/ml COLIRIO EN SOLUCION	Laboratorios Thea S.A.	59248	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NORFLOXACINO DARI PHARMA 400 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Dari Pharma S.L.	64083	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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