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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/07/14 | Not Applicable | Completed | Jagiellonian University | ||
2023/04/18 | Phase 2 | Completed | |||
2022/03/31 | Phase 1 | Recruiting | Central Hospital, Nancy, France | ||
2020/08/03 | Not Applicable | Recruiting | |||
2020/06/11 | Not Applicable | Completed | Ajou University School of Medicine | ||
2020/04/20 | Phase 4 | Completed | Istanbul Medipol University Hospital | ||
2019/07/02 | Phase 3 | Withdrawn | |||
2019/05/01 | Phase 3 | Suspended | |||
2018/08/31 | Phase 4 | Recruiting | |||
2015/10/05 | Not Applicable | Completed | Alejandro Hoberman |
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. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
AFLOCIN CAP 200MG | N/A | N/A | N/A | 12/6/2002 | |
KORUCIN EYE DROPS 0.3%W/V | N/A | N/A | N/A | 5/4/2012 | |
TARIVID EYE DROPS 0.3% | N/A | N/A | N/A | 1/20/1989 | |
FLOVID 200 TAB 200MG | N/A | N/A | N/A | 11/16/2002 | |
SINFLO TABLETS 200MG | N/A | N/A | N/A | 3/30/2016 | |
EARFLO OTIC SOLUTION 0.3% | N/A | N/A | N/A | 10/19/2009 |
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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