ketoconazole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
systemic antifungal agents, miconazole derivatives 1527 65277-42-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ketoconazole
  • (+/-)-ketoconazole
  • brizoral
  • fungarest
  • fungoral
  • ketoderm
  • ketoisdin
  • ketozoral
  • nizoral
  • nizral
  • panfungol
  • ketoconazol
  • R-41400
Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.
  • Molecular weight: 531.43
  • Formula: C26H28Cl2N4O4
  • CLOGP: 3.44
  • LIPINSKI: 1
  • HAC: 8
  • HDO: 0
  • TPSA: 69.06
  • ALOGS: -4.76
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 g V
0.60 g O
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.75 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
June 12, 1981 FDA JANSSEN PHARMS

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
Psoriasis 168.76 13.14 138 12255 86819 63389810
Endocrine ophthalmopathy 65.86 13.14 17 12376 654 63475975
Swelling of eyelid 64.54 13.14 24 12369 3132 63473497
Toxic shock syndrome 62.04 13.14 17 12376 825 63475804
Eyelid disorder 56.68 13.14 19 12374 1830 63474799
Nasal ulcer 56.36 13.14 20 12373 2284 63474345
Seborrhoeic dermatitis 52.90 13.14 16 12377 1105 63475524
Product use in unapproved indication 52.44 13.14 111 12282 178969 63297660
Mean cell haemoglobin increased 44.59 13.14 18 12375 2925 63473704
Dermatitis atopic 38.81 13.14 24 12369 9700 63466929
Cortisol increased 37.91 13.14 10 12383 419 63476210
Papule 36.07 13.14 19 12374 5672 63470957
Hypothalamic pituitary adrenal axis suppression 35.46 13.14 8 12385 172 63476457
Purpura senile 35.22 13.14 10 12383 553 63476076
Tarsal tunnel syndrome 35.03 13.14 10 12383 564 63476065
Dyslipidaemia 34.04 13.14 20 12373 7373 63469256
Adrenal insufficiency 33.77 13.14 28 12365 17887 63458742
Contraindicated product administered 31.60 13.14 3 12390 217645 63258984
Skin disorder 30.40 13.14 33 12360 29474 63447155
Intertrigo 29.96 13.14 9 12384 607 63476022
Eye infection 29.40 13.14 22 12371 12123 63464506
Skin exfoliation 29.27 13.14 39 12354 43063 63433566
Product dose omission issue 28.98 13.14 106 12287 234207 63242422
Vertigo positional 28.54 13.14 13 12380 2836 63473793
Pneumonia mycoplasmal 26.36 13.14 9 12384 916 63475713
Vestibular disorder 26.06 13.14 10 12383 1421 63475208
Xerosis 25.84 13.14 9 12384 973 63475656
Synovial cyst 25.48 13.14 19 12374 10414 63466215
Aspergillus test positive 25.44 13.14 7 12386 345 63476284
Dermatitis 24.91 13.14 23 12370 16935 63459694
Dry skin 23.70 13.14 41 12352 56846 63419783
Abortion spontaneous 23.69 13.14 37 12356 47158 63429471
Resorption bone increased 23.55 13.14 9 12384 1265 63475364
Feeding disorder 23.36 13.14 20 12373 13342 63463287
Impetigo 23.07 13.14 9 12384 1337 63475292
Glossodynia 22.29 13.14 4 12389 178872 63297757
Hypercholesterolaemia 22.22 13.14 24 12369 21310 63455319
Systemic lupus erythematosus 21.49 13.14 7 12386 208911 63267718
Vitamin D decreased 21.40 13.14 17 12376 10225 63466404
Pruritus 20.77 13.14 131 12262 361322 63115307
Flatulence 19.97 13.14 29 12364 34673 63441956
Exposure during pregnancy 19.74 13.14 71 12322 155476 63321153
Wound 19.60 13.14 4 12389 163259 63313370
Pelvic pain 19.21 13.14 18 12375 13501 63463128
Drug interaction 19.17 13.14 92 12301 229039 63247590
Deafness bilateral 19.06 13.14 8 12385 1434 63475195
Drug ineffective for unapproved indication 17.50 13.14 27 12366 34036 63442593
Otitis media 16.85 13.14 11 12382 4880 63471749
Skin ulcer 16.60 13.14 30 12363 43015 63433614
Lower respiratory tract infection 16.39 13.14 3 12390 132304 63344325
Drug clearance increased 16.18 13.14 4 12389 129 63476500
Blood uric acid decreased 16.04 13.14 6 12387 795 63475834
Toxicity to various agents 15.78 13.14 15 12378 247235 63229394
Psoriatic arthropathy 15.40 13.14 46 12347 91474 63385155
Hypertrophy 15.40 13.14 5 12388 436 63476193
Seborrhoeic keratosis 15.36 13.14 8 12385 2334 63474295
Discomfort 14.91 13.14 7 12386 167367 63309262
Pustule 14.68 13.14 7 12386 1692 63474937
Haematopoietic neoplasm 14.65 13.14 3 12390 40 63476589
Skin laceration 14.58 13.14 20 12373 22688 63453941
Product administration interrupted 14.55 13.14 10 12383 4826 63471803
Hepatic enzyme increased 14.47 13.14 11 12382 202317 63274312
Skin burning sensation 14.46 13.14 15 12378 12719 63463910
Infusion related reaction 14.41 13.14 16 12377 245505 63231124
Eczema 14.40 13.14 24 12369 32267 63444362
Arthrodesis 14.02 13.14 8 12385 2793 63473836
Hypokalaemia 13.69 13.14 48 12345 103756 63372873

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
Psoriasis 53.29 13.27 63 10808 38749 34907311
Seborrhoeic dermatitis 49.51 13.27 19 10852 1689 34944371
Skin exfoliation 33.53 13.27 42 10829 27390 34918670
Pruritus 30.29 13.27 105 10766 141876 34804184
Prostatic specific antigen increased 29.21 13.27 29 10842 14651 34931409
Melanocytic naevus 28.11 13.27 14 10857 2330 34943730
Therapeutic response unexpected 26.64 13.27 23 10848 9734 34936326
Colour vision tests normal 25.53 13.27 4 10867 4 34946056
Toxicity to various agents 24.66 13.27 16 10855 200346 34745714
Anaplastic astrocytoma 24.52 13.27 6 10865 114 34945946
Product dose omission issue 24.19 13.27 87 10784 119624 34826436
Eczema 23.77 13.27 29 10842 18407 34927653
Central vision loss 22.08 13.27 4 10867 15 34946045
Alcohol intolerance 20.59 13.27 7 10864 439 34945621
Bone disorder 19.76 13.27 16 10855 6199 34939861
Seborrhoeic keratosis 19.53 13.27 9 10862 1262 34944798
Dermatitis 19.38 13.27 19 10852 9449 34936611
Product use in unapproved indication 18.54 13.27 79 10792 117420 34828640
Rash 17.61 13.27 124 10747 222628 34723432
Actinic elastosis 17.56 13.27 4 10867 55 34946005
Transient aphasia 17.31 13.27 6 10865 399 34945661
Vitamin E deficiency 17.07 13.27 3 10868 9 34946051
Scab 16.99 13.27 13 10858 4641 34941419
Rhabdomyolysis 16.81 13.27 53 10818 68110 34877950
Papule 16.08 13.27 12 10859 4127 34941933
Lentigo 16.03 13.27 6 10865 498 34945562
Blood testosterone decreased 15.53 13.27 12 10859 4345 34941715
Guttate psoriasis 15.52 13.27 5 10866 265 34945795
Skin papilloma 15.25 13.27 9 10862 2094 34943966
Herpes virus infection 15.15 13.27 10 10861 2832 34943228
Polyarteritis nodosa 14.94 13.27 5 10866 299 34945761
Drug ineffective 14.37 13.27 210 10661 456541 34489519
Metastases to bone 14.10 13.27 18 10853 11952 34934108
Hepatitis fulminant 13.77 13.27 11 10860 4179 34941881
Hormone level abnormal 13.46 13.27 5 10866 406 34945654
Dermatitis atopic 13.38 13.27 12 10859 5335 34940725

FDA Adverse Event Reporting System (Geriatric)

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
Psoriasis 141.88 12.33 132 16985 89455 79637816
Endocrine ophthalmopathy 62.89 12.33 17 17100 711 79726560
Swelling of eyelid 61.33 12.33 25 17092 3786 79723485
Nasal ulcer 55.94 12.33 20 17097 2120 79725151
Toxic shock syndrome 53.82 12.33 17 17100 1232 79726039
Eyelid disorder 53.66 12.33 19 17098 1959 79725312
Cortisol increased 48.36 12.33 13 17104 532 79726739
Product dose omission issue 48.02 12.33 139 16978 247398 79479873
Seborrhoeic dermatitis 45.38 12.33 17 17100 2056 79725215
Dermatitis atopic 43.39 12.33 27 17090 10029 79717242
Toxicity to various agents 37.51 12.33 22 17095 421518 79305753
Mean cell haemoglobin increased 36.46 12.33 18 17099 4267 79723004
Impetigo 34.67 12.33 14 17103 2069 79725202
Vitamin D decreased 34.29 12.33 23 17094 9702 79717569
Adrenal insufficiency 32.20 12.33 35 17082 28452 79698819
Rhabdomyolysis 31.65 12.33 69 17048 103062 79624209
Eczema 31.06 12.33 41 17076 40777 79686494
Purpura senile 30.45 12.33 9 17108 521 79726750
Tarsal tunnel syndrome 30.35 12.33 9 17108 527 79726744
Hypothalamic pituitary adrenal axis suppression 29.77 12.33 8 17109 327 79726944
Drug interaction 28.46 12.33 169 16948 415014 79312257
Dyslipidaemia 28.38 12.33 22 17095 11611 79715660
Colour vision tests normal 27.02 12.33 4 17113 4 79727267
Eye infection 25.78 12.33 21 17096 11899 79715372
Vertigo positional 25.43 12.33 13 17104 3317 79723954
Drug abuse 24.59 12.33 3 17114 162688 79564583
Anaplastic astrocytoma 24.58 12.33 6 17111 166 79727105
Flatulence 23.81 12.33 37 17080 42687 79684584
Contraindicated product administered 23.58 12.33 3 17114 157535 79569736
Therapeutic response unexpected 23.41 12.33 25 17092 19921 79707350
Vestibular disorder 22.95 12.33 11 17106 2444 79724827
Intertrigo 22.60 12.33 8 17109 824 79726447
Synovial cyst 22.33 12.33 18 17099 10047 79717224
Central vision loss 22.31 12.33 4 17113 22 79727249
Pelvic pain 21.69 12.33 20 17097 13361 79713910
Resorption bone increased 21.45 12.33 9 17108 1466 79725805
Pneumonia mycoplasmal 21.43 12.33 9 17108 1469 79725802
Skin disorder 21.19 12.33 31 17086 33912 79693359
Hypercholesterolaemia 20.42 12.33 25 17092 23070 79704201
Dermatitis 20.36 12.33 24 17093 21297 79705974
Pruritus 19.41 12.33 148 16969 394500 79332771
Headache 18.54 12.33 218 16899 653554 79073717
Transient aphasia 18.49 12.33 6 17111 474 79726797
Deafness bilateral 18.06 12.33 9 17108 2176 79725095
Cortisol free urine decreased 17.52 12.33 3 17114 12 79727259
Feeding disorder 16.70 12.33 19 17098 16235 79711036
Vitamin E deficiency 16.37 12.33 3 17114 19 79727252
Skin laceration 16.02 12.33 25 17092 28937 79698334
Lower respiratory tract infection 16.01 12.33 4 17113 129216 79598055
Dry skin 15.96 12.33 41 17076 67954 79659317
Aspergillus test positive 15.66 12.33 6 17111 772 79726499
Infusion related reaction 15.41 12.33 16 17101 230221 79497050
Guttate psoriasis 14.65 12.33 5 17112 462 79726809
Alcohol intolerance 14.46 12.33 5 17112 480 79726791
Arthrodesis 14.44 12.33 8 17109 2399 79724872
Hepatotoxicity 14.22 12.33 33 17084 51319 79675952
Skin ulcer 14.13 12.33 34 17083 54116 79673155
Hepatitis fulminant 14.05 12.33 12 17105 7250 79720021
Drug intolerance 13.90 12.33 22 17095 264097 79463174
Polyarteritis nodosa 13.89 12.33 5 17112 540 79726731
Skin exfoliation 13.74 12.33 34 17083 55066 79672205
Wound 13.63 12.33 4 17113 116175 79611096
General physical health deterioration 13.50 12.33 24 17093 275214 79452057
Muscle spasms 13.16 12.33 73 17044 174657 79552614
Drug clearance increased 13.00 12.33 4 17113 266 79727005
Myalgia 12.96 12.33 76 17041 185565 79541706
Blood uric acid decreased 12.74 12.33 6 17111 1282 79725989
Adrenocortical insufficiency acute 12.70 12.33 8 17109 3035 79724236
Skin candida 12.69 12.33 7 17110 2080 79725191
Penile oedema 12.34 12.33 4 17113 315 79726956

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D01AC08 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Imidazole and triazole derivatives
ATC G01AF11 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Imidazole derivatives
ATC H02CA03 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
CORTICOSTEROIDS FOR SYSTEMIC USE
ANTIADRENAL PREPARATIONS
Anticorticosteroids
ATC J02AB02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
Imidazole derivatives
FDA CS M0002083 Azoles
FDA EPC N0000175487 Azole Antifungal
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D065088 Steroid Synthesis Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190115 Cytochrome P450 3A5 Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Tinea pedis indication 6020002 DOID:12403
Histoplasmosis indication 12962009 DOID:1731
Hypercortisolism indication 47270006
Candidiasis of skin indication 49883006
Seborrheic dermatitis indication 50563003 DOID:8741
Pityriasis versicolor indication 56454009 DOID:9060
Paracoccidioidomycosis indication 59925007 DOID:12662
Coccidioidomycosis indication 60826002 DOID:13450
Blastomycosis indication 69996000 DOID:12663
Disseminated candidiasis indication 70572005
Candidiasis of mouth indication 79740000 DOID:14262
Tinea corporis indication 84849002
Chromoblastomycosis indication 187079000
Pityriasis simplex indication 200767005
Tinea cruris indication 399029005
Paronychia off-label use 71906005 DOID:13117
Advanced Prostatic Carcinoma off-label use
Torsades de pointes contraindication 31722008
Achlorhydria contraindication 47481007
Prolonged QT interval contraindication 111975006
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Congenital long QT syndrome contraindication 442917000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.84 Basic
pKa2 3.5 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
Steroid 17-alpha-hydroxylase/17,20 lyase Enzyme INHIBITOR IC50 7.28 WOMBAT-PK DRUG LABEL
Cytochrome P450 11B1, mitochondrial Enzyme INHIBITOR IC50 6.90 SCIENTIFIC LITERATURE DRUG LABEL
Cytochrome P450 3A4 Enzyme Ki 7 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 6 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 6.55 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 4.62 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 5.08 DRUG MATRIX
Histamine H2 receptor GPCR Ki 4.67 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 5.03 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5.46 WOMBAT-PK
Sodium-dependent dopamine transporter Transporter Ki 4.73 DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 4.84 DRUG MATRIX
Delta-type opioid receptor GPCR Ki 5.35 DRUG MATRIX
Bile salt export pump Transporter IC50 5.54 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 4.40 CHEMBL
Aromatase Enzyme Ki 6.40 CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial Enzyme IC50 6.47 CHEMBL
Potassium voltage-gated channel subfamily A member 10 Ion channel BLOCKER IC50 6.30 IUPHAR
Cytochrome P450 2C19 Enzyme IC50 4.72 CHEMBL
Thromboxane-A synthase Enzyme IC50 5.67 DRUG MATRIX
Lanosterol 14-alpha demethylase Enzyme app Ki 7.20 WOMBAT-PK
Indoleamine 2,3-dioxygenase 1 Enzyme IC50 4.60 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 5.58 CHEMBL
Substance-K receptor GPCR Ki 5.24 DRUG MATRIX
Cytochrome P450 3A5 Enzyme IC50 6.92 CHEMBL
1,25-dihydroxyvitamin D(3) 24-hydroxylase, mitochondrial Enzyme IC50 6.51 WOMBAT-PK
Cytochrome P450 21 Enzyme IC50 5.05 CHEMBL
Sodium/nucleoside cotransporter 1 Transporter Ki 5.82 DRUG MATRIX
Cytochrome P450 11B2, mitochondrial Enzyme INHIBITOR IC50 7.17 SCIENTIFIC LITERATURE
Alpha-2A adrenergic receptor GPCR Ki 5.13 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.72 WOMBAT-PK
Lanosterol 14-alpha demethylase Enzyme INHIBITOR IC50 7 WOMBAT-PK CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 5.27 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 4.90 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 5.21 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.01 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 4.45 CHEMBL
Gonadotropin-releasing hormone receptor GPCR Kd 9.66 CHEMBL
Cytochrome P450 11B1 Enzyme IC50 6.82 CHEMBL
Cytochrome P450 11A1 Enzyme IC50 5.91 CHEMBL
Cytochrome P450 24A1 Enzyme IC50 4.70 CHEMBL
Cytochrome P450 7A1 Enzyme IC50 6.71 CHEMBL
Cytochrome P450 51 Enzyme Ki 7.19 CHEMBL
Bile salt export pump Transporter IC50 4.81 CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial Enzyme IC50 6.44 CHEMBL
Cytochrome P450 17A1 Enzyme IC50 6.69 CHEMBL

External reference:

IDSource
4019271 VUID
N0000147470 NUI
D00351 KEGG_DRUG
4019271 VANDF
C0022625 UMLSCUI
CHEBI:47519 CHEBI
KTN PDB_CHEM_ID
CHEMBL157101 ChEMBL_ID
CHEMBL295698 ChEMBL_ID
D007654 MESH_DESCRIPTOR_UI
DB01026 DRUGBANK_ID
2568 IUPHAR_LIGAND_ID
4594 INN_ID
R9400W927I UNII
456201 PUBCHEM_CID
202692 RXNORM
2701 MMSL
31001 MMSL
4945 MMSL
d00103 MMSL
002903 NDDF
387216007 SNOMEDCT_US
40232005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-3219 CREAM 20 mg TOPICAL ANDA 17 sections
ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 0168-0099 CREAM 20 mg TOPICAL ANDA 16 sections
Ketaconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-7007 AEROSOL, FOAM 20 mg TOPICAL NDA authorized generic 26 sections
EXTINA HUMAN PRESCRIPTION DRUG LABEL 1 0378-8136 AEROSOL, FOAM 20 mg TOPICAL NDA 25 sections
Xolegel HUMAN PRESCRIPTION DRUG LABEL 1 16110-080 GEL 20 mg TOPICAL NDA 27 sections
KETOCONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 16590-998 TABLET 200 mg ORAL ANDA 22 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 16714-955 CREAM 20 mg TOPICAL ANDA 18 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 21695-554 CREAM 20 mg TOPICAL ANDA 19 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 21695-555 CREAM 20 mg TOPICAL ANDA 19 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 21695-556 CREAM 20 mg TOPICAL ANDA 19 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 21695-562 TABLET 200 mg ORAL ANDA 23 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 21922-025 CREAM 20 mg TOPICAL ANDA 15 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 33261-739 TABLET 200 mg ORAL ANDA 26 sections
KETOCONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 35573-433 TABLET 200 mg ORAL ANDA 15 sections
KETOCONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 35573-433 TABLET 200 mg ORAL ANDA 15 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 43063-882 TABLET 200 mg ORAL ANDA 26 sections
Ketodan HUMAN PRESCRIPTION DRUG LABEL 1 43538-530 AEROSOL, FOAM 20 mg TOPICAL ANDA 31 sections
Ketodan HUMAN PRESCRIPTION DRUG LABEL 1 43538-530 AEROSOL, FOAM 20 mg TOPICAL ANDA 31 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 45802-465 SHAMPOO, SUSPENSION 20 mg TOPICAL ANDA 18 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 45802-465 SHAMPOO, SUSPENSION 20 mg TOPICAL ANDA 18 sections
ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 45802-532 AEROSOL, FOAM 2 g TOPICAL ANDA 27 sections
ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 45802-532 AEROSOL, FOAM 2 g TOPICAL ANDA 27 sections
ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-0720 CREAM 20 mg TOPICAL ANDA 16 sections
ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-0720 CREAM 20 mg TOPICAL ANDA 16 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-1220 SHAMPOO, SUSPENSION 20 mg TOPICAL ANDA 18 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-1524 CREAM 20 mg TOPICAL ANDA 18 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-1675 CREAM 20 mg TOPICAL ANDA 18 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-1992 TABLET 200 mg ORAL ANDA 26 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-3288 SHAMPOO, SUSPENSION 20.50 mg TOPICAL ANDA 17 sections
Ketoconazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-5265 CREAM 20 mg TOPICAL ANDA 17 sections