ofloxacin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibacterials, nalidixic acid derivatives 1981 82419-36-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • gailuoxian
  • ofloxacine
  • oxaldin
  • prifloxcin
  • prifloxin
  • ofloxacin
  • ofloxacin hydrochloride
  • ofloxacin HCl
A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.
  • Molecular weight: 361.37
  • Formula: C18H20FN3O4
  • CLOGP: -0.51
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 73.32
  • ALOGS: -2.40
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.54 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 64 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 31.62 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.75 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 8.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 28, 1990 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Endophthalmitis 72.77 16.06 24 6161 3254 46676623
Toxic anterior segment syndrome 65.47 16.06 20 6165 2117 46677760
Drug reaction with eosinophilia and systemic symptoms 54.67 16.06 39 6146 29509 46650368
Corneal perforation 50.33 16.06 12 6173 494 46679383
Acute kidney injury 50.33 16.06 102 6083 235753 46444124
Drug resistance 49.40 16.06 30 6155 17338 46662539
Corneal oedema 48.70 16.06 15 6170 1631 46678246
Rash maculo-papular 45.25 16.06 34 6151 27840 46652037
Hypopyon 44.71 16.06 12 6173 799 46679078
Eye pain 42.97 16.06 33 6152 27907 46651970
Corneal deposits 42.84 16.06 9 6176 206 46679671
Cholestasis 41.87 16.06 32 6153 26861 46653016
Corneal erosion 40.73 16.06 9 6176 263 46679614
Cataract 40.00 16.06 39 6146 45376 46634501
Eosinophilia 39.35 16.06 27 6158 19190 46660687
Agranulocytosis 35.87 16.06 27 6158 22158 46657719
Keratitis fungal 35.35 16.06 7 6178 118 46679759
Confusional state 33.85 16.06 69 6116 159823 46520054
Renal necrosis 33.67 16.06 6 6179 55 46679822
Tendon pain 33.40 16.06 13 6172 2837 46677040
Psychotic disorder due to a general medical condition 32.03 16.06 7 6178 194 46679683
Drug hypersensitivity 30.75 16.06 86 6099 243739 46436138
Retinal pigment epithelial tear 30.71 16.06 7 6178 236 46679641
Gingival ulceration 29.67 16.06 9 6176 929 46678948
Acute generalised exanthematous pustulosis 28.69 16.06 17 6168 9388 46670489
Tendonitis 26.75 16.06 19 6166 14258 46665619
Hyperthermia 25.80 16.06 15 6170 7999 46671878
Anuria 25.64 16.06 17 6168 11414 46668463
Ulcerative keratitis 25.25 16.06 10 6175 2283 46677594
Periodontal disease 24.55 16.06 9 6176 1666 46678211
Reversible cerebral vasoconstriction syndrome 24.34 16.06 9 6176 1708 46678169
Tendon disorder 23.45 16.06 12 6173 4983 46674894
Visual impairment 22.07 16.06 35 6150 66654 46613223
International normalised ratio increased 21.94 16.06 29 6156 46854 46633023
Hepatitis 21.75 16.06 24 6161 32191 46647686
Visual acuity reduced 21.37 16.06 20 6165 22093 46657784
Periodontitis 21.25 16.06 10 6175 3466 46676411
Pyelonephritis 21.14 16.06 17 6168 15340 46664537
Tendon rupture 21.03 16.06 13 6172 7746 46672131
Thrombocytopenia 20.39 16.06 49 6136 126532 46553345
Hepatitis cholestatic 20.19 16.06 12 6173 6665 46673212
Face oedema 19.82 16.06 18 6167 19135 46660742
Keratolysis exfoliativa acquired 19.63 16.06 3 6182 9 46679868
Toxic epidermal necrolysis 19.35 16.06 19 6166 22259 46657618
Eye infection 19.10 16.06 13 6172 9110 46670767
Mucosal erosion 18.61 16.06 7 6178 1391 46678486
Corneal epithelium defect 18.47 16.06 5 6180 344 46679533
Necrosis 18.24 16.06 10 6175 4770 46675107
Hepatocellular injury 18.23 16.06 21 6164 29501 46650376
Eye irritation 17.96 16.06 16 6169 16598 46663279
Aortic dissection 17.73 16.06 7 6178 1585 46678292
Encephalopathy 17.63 16.06 22 6163 33567 46646310
Shock haemorrhagic 17.37 16.06 12 6173 8612 46671265
Central nervous system immune reconstitution inflammatory response 16.88 16.06 3 6182 27 46679850
Factor V inhibition 16.81 16.06 4 6181 163 46679714
Clostridium difficile colitis 16.45 16.06 16 6169 18537 46661340

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug reaction with eosinophilia and systemic symptoms 127.13 16.17 76 5904 28412 29918086
Type 2 lepra reaction 91.24 16.17 20 5960 367 29946131
Hepatocellular injury 78.87 16.17 54 5926 25417 29921081
Tendonitis 77.69 16.17 36 5944 8000 29938498
Rash maculo-papular 69.63 16.17 50 5930 25368 29921130
Cholestasis 68.17 16.17 49 5931 24901 29921597
Agranulocytosis 57.44 16.17 42 5938 21900 29924598
Toxic epidermal necrolysis 53.07 16.17 37 5943 17903 29928595
Eosinophilia 52.60 16.17 40 5940 22120 29924378
Ulcerative keratitis 49.18 16.17 16 5964 1373 29945125
Corneal oedema 41.98 16.17 14 5966 1298 29945200
Acute kidney injury 41.33 16.17 134 5846 273708 29672790
Keratitis fungal 41.18 16.17 8 5972 78 29946420
Corneal deposits 39.99 16.17 9 5971 187 29946311
Tendon rupture 39.89 16.17 22 5958 7042 29939456
Eye pain 38.86 16.17 26 5954 11763 29934735
Visual acuity reduced 38.47 16.17 29 5951 15817 29930681
Laryngeal haematoma 38.19 16.17 8 5972 117 29946381
Prostatitis 35.40 16.17 18 5962 4889 29941609
Skin hyperpigmentation 33.96 16.17 15 5965 2979 29943519
Endophthalmitis 31.80 16.17 15 5965 3465 29943033
Tendon disorder 30.96 16.17 13 5967 2283 29944215
Corneal epithelium defect 30.35 16.17 8 5972 327 29946171
Corneal opacity 30.32 16.17 9 5971 570 29945928
Tendon pain 29.76 16.17 13 5967 2514 29943984
Motion sickness 29.75 16.17 7 5973 178 29946320
Distal intestinal obstruction syndrome 29.67 16.17 8 5972 357 29946141
Retinal pigment epithelial tear 27.41 16.17 7 5973 252 29946246
Upper airway obstruction 26.11 16.17 8 5972 564 29945934
Purpura 25.89 16.17 19 5961 9948 29936550
Haemolytic anaemia 25.81 16.17 19 5961 9991 29936507
Anterior chamber cell 24.79 16.17 7 5973 371 29946127
Eye inflammation 24.54 16.17 10 5970 1627 29944871
Hyperthermia 23.44 16.17 18 5962 10081 29936417
Tendon discomfort 22.72 16.17 6 5974 247 29946251
Hyperacusis 21.53 16.17 7 5973 599 29945899
Drug resistance 21.17 16.17 23 5957 20110 29926388
Corneal thinning 20.69 16.17 5 5975 143 29946355
Corneal perforation 20.56 16.17 5 5975 147 29946351
Pudendal canal syndrome 20.48 16.17 3 5977 3 29946495
Red blood cell vacuolisation 20.48 16.17 3 5977 3 29946495
Corneal disorder 19.51 16.17 7 5973 807 29945691
Intra-abdominal haemorrhage 19.02 16.17 9 5971 2093 29944405
Hypopyon 18.98 16.17 6 5974 469 29946029
Dysaesthesia 18.62 16.17 9 5971 2192 29944306
Intraocular pressure increased 18.59 16.17 12 5968 5108 29941390
Vascular purpura 18.10 16.17 8 5972 1589 29944909
Cataract 18.00 16.17 22 5958 21813 29924685
Vasculitis necrotising 17.64 16.17 6 5974 591 29945907
Muscle contractions involuntary 17.30 16.17 8 5972 1765 29944733
Tuberculoma of central nervous system 17.27 16.17 5 5975 290 29946208
Neuropathy peripheral 16.98 16.17 41 5939 70434 29876064
Neuralgia 16.67 16.17 15 5965 10451 29936047
Immune reconstitution inflammatory syndrome 16.42 16.17 14 5966 9087 29937411
Prothrombin time ratio decreased 16.24 16.17 5 5975 358 29946140
Thrombocytopenia 16.18 16.17 62 5918 136982 29809516

Pharmacologic Action:

SourceCodeDescription
ATC J01MA01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
QUINOLONE ANTIBACTERIALS
Fluoroquinolones
ATC J01RA09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AE01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Fluoroquinolones
ATC S02AA16 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
FDA CS M0023650 Quinolones
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000892 Anti-Infective Agents, Urinary
MeSH PA D000970 Antineoplastic Agents
MeSH PA D065609 Cytochrome P-450 CYP1A2 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D059005 Topoisomerase II Inhibitors
CHEBI has role CHEBI:35441 anti-infective drugs
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:59517 dna synthesis inhibitors
FDA EPC N0000175937 Quinolone Antimicrobial

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Otitis externa indication 3135009
Typhoid fever indication 4834000 DOID:13258
Septicemia due to Escherichia coli indication 9323009
Prostatitis indication 9713002 DOID:14654
Infection due to Pseudomonas aeruginosa indication 11218009
Gonorrhea indication 15628003 DOID:7551
Enteric campylobacteriosis indication 18081009
Infectious diarrheal disease indication 19213003 DOID:13250
Infection of skin AND/OR subcutaneous tissue indication 19824006
Acute gonococcal cervicitis indication 20943002 DOID:10615
Staphylococcal pneumonia indication 22754005
Acute gonococcal urethritis indication 29864006
Acute bacterial peritonitis indication 31860008
Bronchitis indication 32398004 DOID:6132
Postoperative infection indication 33910007
Pneumonia due to Streptococcus indication 34020007
Shigellosis indication 36188001
Cystitis indication 38822007 DOID:1679
Pneumonia due to Pseudomonas indication 41381004
Gonorrhea of rectum indication 42746002
Pyelonephritis indication 45816000 DOID:11400
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Lower respiratory tract infection indication 50417007
Pneumonia due to Escherichia coli indication 51530003
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Acute gonococcal endometritis indication 65295003 DOID:7527
Acute maxillary sinusitis indication 68272006 DOID:2050
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Abdominal abscess indication 75100008
Acute bacterial sinusitis indication 75498004
Nongonococcal urethritis indication 84619001
Infective otitis externa indication 86981007 DOID:9463
Chronic tubotympanic suppurative otitis media indication 87665008 DOID:14435
Infection of bone indication 111253001
Female genital tract infection indication 125585007
Infectious disease of abdomen indication 128070006
Bacterial conjunctivitis indication 128350005 DOID:9700
Infection due to Enterobacteriaceae indication 128945009
Urethritis due to Chlamydia trachomatis indication 179101003
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Chlamydial pelvic inflammatory disease indication 188463006
Acute Moraxella catarrhalis bronchitis indication 195722003
Proteus pneumonia indication 195888009
Malignant otitis externa due to Pseudomonas aeruginosa indication 232230009
Acute bacterial bronchitis indication 233598009
Pneumonia indication 233604007 DOID:552
Pneumococcal pneumonia indication 233607000
Chlamydial pneumonia indication 233609002
Infective cystitis indication 236620008
Chancroid indication 266143009 DOID:13778
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Infectious disorder of joint indication 363162000
Infection due to Staphylococcus aureus indication 406602003
Anthrax indication 409498004 DOID:7427
Acute osteomyelitis indication 409780002
Nosocomial pneumonia indication 425464007
Acute exacerbation of chronic bronchitis indication 425748003
Urinary tract infection caused by Klebsiella indication 369001000119100
Pseudomonas Aeruginosa Urinary Tract Infection indication
Enterobacter Pneumonia indication
Mixed Gonococcal and Chlamydia Infection of the Urethra indication
Complicated Bacteroides Peritonitis indication
Pseudomonas Aeruginosa Cystitis indication
Skin and Skin Structure Serratia Infection indication
Complicated Bacterial Peritonitis indication
Chlamydia Cervicitis indication
Haemophilus Influenzae Chronic Bronchitis indication
Complicated Skin and Skin Structure Proteus Infection indication
Streptococcus Pneumoniae Bronchitis indication
Moraxella Catarrhalis Chronic Bronchitis indication
Chronic Staphylococcus epidermidis Prostatitis indication
Pseudomonas Aeruginosa Osteomyelitis indication
Haemophilus Parainfluenzae Pneumonia indication
Enterobacter Osteomyelitis indication
Providencia Urinary Tract Infection indication
Nosocomial Pneumonia due to Serratia Marcescens indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea indication
Complicated Proteus UTI indication
Chronic Bacterial Prostatitis indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Proteus Prostatitis indication
Staphylococcus Epidermidis Skin and Skin Structure Infection indication
Complicated Skin and Skin Structure Enterococcus Faecalis Infection indication
Serratia Joint Infection indication
Skin and Skin Structure Morganella Morganii Infection indication
Complicated Urinary Tract Infections indication
Nosocomial Pneumonia due to Escherichia Coli indication
Skin and Skin Structure Citrobacter Infection indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa indication
Chronic Enterococcus faecalis Prostatitis indication
Complicated Skin and Skin Structure Streptococcus Pyogenes Infection indication
Colorectal Surgery Infection Prevention indication
Bacterial Corneal Ulcer Infection indication
Legionella Pneumophila Pneumonia indication
Complicated E. Coli Peritonitis indication
Nosocomial Pneumonia due to Methicillin-Sensitive Staphylococcus Aureus indication
Mixed Gonococcal and Chlamydia Infection of the Cervix indication
Complicated Skin and Skin Structure Staphylococcus Aureus Infection indication
Serratia Urinary Tract Infection indication
Diarrhea due to E. Coli indication
Moraxella Catarrhalis Pneumonia indication
E. Coli Pyelonephritis indication
Serratia Osteomyelitis indication
Staphylococcus Epidermidis Urinary Tract Infection indication
E. Coli Cystitis indication
Enterobacter Cystitis indication
Pseudomonas Aeruginosa Joint Infection indication
Chronic Escherichia coli Prostatitis indication
Complicated UTI with Pseudomonas Aeruginosa indication
Citrobacter Urinary Tract Infection indication
Citrobacter Complicated UTI indication
Skin and Skin Structure Proteus Infection indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Staphylococcus Aureus Otitis Externa indication
Klebsiella Nosocomial Pneumonia indication
Enterococcus Complicated UTI indication
Haemophilus Parainfluenzae Bronchitis indication
Citrobacter Cystitis indication
Enterococcus Urinary Tract Infection indication
Haemophilus Influenzae Bronchitis indication
Staphylococcus Saprophyticus Urinary Tract Infection indication
Staphylococcus Aureus Bronchitis indication
Morganella Morganii Urinary Tract Infection indication
Staphylococcus Cystitis indication
Complicated Klebsiella Peritonitis indication
Nosocomial Pneumonia due to Streptococcus Pneumoniae indication
Complicated Skin and Skin Structure Infection indication
Nosocomial Pneumonia due to Klebsiella Pneumoniae indication
EnterobacterJoint Infection indication
Nosocomial Pneumonia due to Haemophilus Influenzae indication
Skin and Skin Structure Providencia Infection indication
Proteus Cystitis indication
Vaginal Hysterectomy Infection Prevention indication
Inhalational anthrax off-label use 11389007
Traveler's diarrhea off-label use 11840006
Acute tuberculosis off-label use 25629007
Salmonella septicemia off-label use 49786009
Cutaneous anthrax off-label use 84980006 DOID:7426
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Pulmonary tuberculosis off-label use 154283005 DOID:2957
Diverticulitis of gastrointestinal tract off-label use 271366000
Ventilator-acquired pneumonia off-label use 429271009
Diabetic Foot Infection off-label use
Prevention of Meningococcal Meningitis off-label use
Hallucinations contraindication 7011001
Achilles tendinitis contraindication 11654001
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Torsades de pointes contraindication 31722008
Transplantation of heart contraindication 32413006
Dehydration contraindication 34095006
Tendinitis contraindication 34840004 DOID:971
Hypokalemia contraindication 43339004
Bradycardia contraindication 48867003
Hepatic failure contraindication 59927004
Transplant of kidney contraindication 70536003
Diabetes mellitus contraindication 73211009 DOID:9351
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Transplant of lung contraindication 88039007
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Pancytopenia contraindication 127034005 DOID:12450
Superimposed infection contraindication 193198003
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Rhabdomyolysis contraindication 240131006
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Viral ear infection contraindication 312137007
Pseudomembranous enterocolitis contraindication 397683000
Myocardial ischemia contraindication 414795007 DOID:3393
Traumatic rupture of tendon contraindication 415749005
Congenital long QT syndrome contraindication 442917000
Severe Cerebral Arteriosclerosis contraindication
Tremors contraindication
Shoulder Tendonitis contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.12 acidic
pKa2 8.29 Basic
pKa3 1.12 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR IC50 4.41 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter IC50 4.54 WOMBAT-PK
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel IC50 4.23 WOMBAT-PK
Histamine H3 receptor GPCR IC50 4.55 WOMBAT-PK
DNA gyrase subunit A Enzyme INHIBITOR IC50 5.28 WOMBAT-PK CHEMBL
Gag-Pro-Pol polyprotein Polyprotein IC50 4.82 WOMBAT-PK
GABA-A receptor; anion channel Ion channel IC50 4.96 CHEMBL
Trypsin Unclassified AC50 5.03 CHEMBL
DNA gyrase subunit B Enzyme WOMBAT-PK
CAAX prenyl protease 1 Unclassified AC50 5.71 CHEMBL

External reference:

IDSource
4019567 VUID
N0000147667 NUI
D00453 KEGG_DRUG
118120-51-7 SECONDARY_CAS_RN
4019567 VANDF
C0028902 UMLSCUI
CHEBI:7731 CHEBI
XED PDB_CHEM_ID
CHEMBL4 ChEMBL_ID
D015242 MESH_DESCRIPTOR_UI
DB01165 DRUGBANK_ID
10918 IUPHAR_LIGAND_ID
5322 INN_ID
A4P49JAZ9H UNII
4583 PUBCHEM_CID
7623 RXNORM
47400 MMSL
5197 MMSL
d00114 MMSL
003563 NDDF
004136 NDDF
387551000 SNOMEDCT_US
441553007 SNOMEDCT_US
96086002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7189 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 24 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0760 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0761 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
OCUFLOX HUMAN PRESCRIPTION DRUG LABEL 1 11980-779 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 13985-602 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 25 sections
OFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-175 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 10 sections
OFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-931 SOLUTION/ DROPS 3 mg AURICULAR (OTIC) ANDA 11 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 17478-713 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 23 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-439 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 19 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-881 SOLUTION/ DROPS 3 mg AURICULAR (OTIC) ANDA 23 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 24208-410 SOLUTION 3 mg AURICULAR (OTIC) ANDA 18 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 24208-434 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 20 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 33261-737 SOLUTION 3 mg AURICULAR (OTIC) ANDA 18 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 42254-257 SOLUTION 3 mg AURICULAR (OTIC) ANDA 18 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0891 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin Otic HUMAN PRESCRIPTION DRUG LABEL 1 50090-1090 SOLUTION 3 mg AURICULAR (OTIC) ANDA 20 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-1346 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-3836 SOLUTION/ DROPS 3 mg AURICULAR (OTIC) ANDA 23 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5186 SOLUTION 3 mg OPHTHALMIC ANDA 21 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5209 SOLUTION 3 mg OPHTHALMIC ANDA 21 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5210 SOLUTION 3 mg OPHTHALMIC ANDA 21 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50090-5425 SOLUTION 3 mg OPHTHALMIC ANDA 13 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50383-024 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 21 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50383-025 SOLUTION/ DROPS 3 mg AURICULAR (OTIC) ANDA 23 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50436-0713 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 50436-6112 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 19 sections
ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 52959-763 SOLUTION 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 53002-1324 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 22 sections
Ofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 53002-1604 SOLUTION 3 mg AURICULAR (OTIC) ANDA 18 sections
Ofloxacin Otic HUMAN PRESCRIPTION DRUG LABEL 1 53002-2604 SOLUTION 3 mg AURICULAR (OTIC) ANDA 20 sections