MedPath

Ofloxacin

Generic Name
Ofloxacin
Brand Names
Ocuflox
Drug Type
Small Molecule
Chemical Formula
C18H20FN3O4
CAS Number
82419-36-1
Unique Ingredient Identifier
A4P49JAZ9H

Overview

A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

Indication

For the treatment of infections (respiratory tract, kidney, skin, soft tissue, UTI), urethral and cervical gonorrhoea.

Associated Conditions

  • Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
  • Acute Otitis Media (AOM)
  • Bacterial Infections
  • Cervicitis
  • Community Acquired Pneumonia (CAP)
  • Complicated Urinary Tract Infection
  • Conjunctivitis
  • Epididymitis
  • Hansen's Disease
  • Nongonococcal urethritis
  • Otitis Externa
  • Prostatitis
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Spontaneous Bacterial Peritonitis (SBP)
  • Traveler's Diarrhea
  • Ulcerative keratitis
  • Acute Pelvic inflammatory disease
  • Acute, uncomplicated Gonorrhea
  • Chronic suppurative Otitis media
  • Uncomplicated Cystitis

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Akorn
50383-025
AURICULAR (OTIC)
3 mg in 1 mL
10/17/2022
DIRECT RX
72189-108
AURICULAR (OTIC)
3 mg in 1 mL
6/11/2020
NuCare Pharmaceuticaals,Inc.
68071-2544
OPHTHALMIC
3 mg in 1 mL
7/17/2023
Lifestar Pharma LLC
70756-650
OPHTHALMIC
3 mg in 1 mL
8/31/2023
Proficient Rx LP
63187-268
OPHTHALMIC
3 mg in 1 mL
4/1/2022
American Regent, Inc.
0517-0760
OPHTHALMIC
3 mg in 1 mL
7/8/2010
RPK Pharmaceuticals, Inc.
53002-6324
OPHTHALMIC
3 mg in 1 mL
8/31/2023
Proficient Rx LP
63187-184
AURICULAR (OTIC)
3 mg in 1 mL
9/1/2022
RPK Pharmaceuticals, Inc.
53002-2604
AURICULAR (OTIC)
3 mg in 1 mL
11/17/2022
Keltman Pharmaceuticals Inc.
68387-106
OPHTHALMIC
3 mg in 1 mL
8/3/2010

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
OFCIN FILM COATED TABLET 400 mg
SIN10118P
TABLET, FILM COATED
400 mg
9/25/1998
FLOVID 200
SIN13219P
TABLET, FILM COATED
200.00 MG
9/28/2006
OFCIN FILM COATED TABLET 200 mg
SIN10119P
TABLET, FILM COATED
200 mg
9/25/1998
OFLOX TABLET 200 mg
SIN11433P
TABLET, FILM COATED
200 mg
12/13/2000
AKILEN TABLET 200 mg
SIN11377P
TABLET, FILM COATED
200 mg
8/24/2000
FUGACIN TABLET 200 mg
SIN08409P
TABLET, FILM COATED
200 mg
10/26/1995

NMPA Drug Approvals

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

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
OCUFLOX ofloxacin 3mg/mL (0.3%) sterile ophthalmic solution
47485
Medicine
A
2/18/1994

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
FLOXIN I.V. LIQ 20MG/ML
ortho pharmaceutical, division of janssen-ortho inc.
02049414
Liquid - Intravenous
20 MG / ML
N/A
FLOXIN TABLETS 300MG
01968416
Tablet - Oral
300 MG
12/31/1990
OCUFLOX
02143291
Solution - Ophthalmic
0.3 % / W/V
12/31/1995
NOVO-OFLOXACIN
novopharm limited
02243475
Tablet - Oral
300 MG
6/11/2004
APO-OFLOXACIN
02248398
Solution - Ophthalmic
0.3 %
1/22/2004
NOVO-OFLOXACIN
novopharm limited
02243474
Tablet - Oral
200 MG
6/11/2004
FLOXIN TABLETS 400MG
01968408
Tablet - Oral
400 MG
12/31/1990
FLOXIN TABLETS 200MG
01968424
Tablet - Oral
200 MG
12/31/1992
OFLOXACIN TABLETS
aa pharma inc
02231529
Tablet - Oral
200 MG
2/4/1998
OFLOXACIN TABLETS
aa pharma inc
02231532
Tablet - Oral
400 MG
2/17/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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