ketoconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
systemic antifungal agents, miconazole derivatives	1527	65277-42-1

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.40	g	V
0.60	g	O
0.20	g	O

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	75 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
June 12, 1981	FDA	JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Psoriasis	114.25	13.86	98	9336	68902	50526788
Cortisol increased	40.11	13.86	10	9424	350	50595340
Hypothalamic pituitary adrenal axis suppression	37.12	13.86	8	9426	145	50595545
Purpura senile	36.30	13.86	10	9424	519	50595171
Tarsal tunnel syndrome	36.11	13.86	10	9424	529	50595161
Product dose omission issue	33.30	13.86	92	9342	183746	50411944
Exposure during pregnancy	31.94	13.86	70	9364	120945	50474745
Adrenal insufficiency	31.52	13.86	24	9410	14219	50581471
Abortion spontaneous	28.49	13.86	37	9397	41735	50553955
Pneumonia mycoplasmal	27.53	13.86	9	9425	840	50594850
Vertigo positional	27.40	13.86	12	9422	2499	50593191
Resorption bone increased	25.99	13.86	9	9425	1002	50594688
Drug interaction	24.23	13.86	87	9347	199534	50396156
Vestibular disorder	23.99	13.86	9	9425	1260	50594430
Aspergillus test positive	21.53	13.86	6	9428	325	50595365
Deafness bilateral	20.68	13.86	8	9426	1218	50594472
Swelling of eyelid	20.66	13.86	9	9425	1851	50593839
Dermatitis atopic	20.48	13.86	11	9423	3575	50592115
Drug clearance increased	17.83	13.86	4	9430	88	50595602
Blood uric acid decreased	17.25	13.86	6	9428	676	50595014
Psoriatic arthropathy	16.94	13.86	31	9403	47001	50548689
Seborrhoeic dermatitis	16.27	13.86	6	9428	801	50594889
Hypertrophy	16.27	13.86	5	9429	382	50595308
Otitis media	15.94	13.86	10	9424	4339	50591351
Haematopoietic neoplasm	14.78	13.86	3	9431	40	50595650
Systemic lupus erythematosus	14.72	13.86	4	9430	140618	50455072
Impetigo	14.12	13.86	6	9428	1161	50594529
Bronchopulmonary aspergillosis allergic	14.00	13.86	6	9428	1185	50594505

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Psoriasis	33.79	13.33	46	9255	32181	29533045
Prostatic specific antigen increased	32.79	13.33	29	9272	12535	29552691
Therapeutic response unexpected	26.75	13.33	22	9279	8616	29556610
Transient aphasia	25.54	13.33	6	9295	94	29565132
Colour vision tests normal	25.49	13.33	4	9297	4	29565222
Anaplastic astrocytoma	24.50	13.33	6	9295	113	29565113
Seborrhoeic dermatitis	24.46	13.33	11	9290	1442	29563784
Central vision loss	22.03	13.33	4	9297	15	29565211
Eczema	21.37	13.33	24	9277	13802	29551424
Alcohol intolerance	21.35	13.33	7	9294	388	29564838
Toxicity to various agents	20.32	13.33	15	9286	173646	29391580
Off label use	19.99	13.33	162	9139	300638	29264588
Rhabdomyolysis	19.20	13.33	52	9249	60756	29504470
Bone disorder	18.48	13.33	15	9286	5768	29559458
Guttate psoriasis	17.98	13.33	5	9296	157	29565069
Vitamin E deficiency	17.04	13.33	3	9298	9	29565217
Metastases to bone	16.71	13.33	18	9283	9880	29555346
Polyarteritis nodosa	16.66	13.33	5	9296	207	29565019
Product dose omission issue	16.53	13.33	67	9234	96316	29468910
Blood testosterone decreased	16.52	13.33	12	9289	3918	29561308
Herpes virus infection	16.11	13.33	10	9291	2521	29562705
Hepatitis fulminant	15.23	13.33	11	9290	3560	29561666
Headache	15.12	13.33	100	9201	173907	29391319
Dermatitis	14.63	13.33	15	9286	7783	29557443
Product use issue	14.28	13.33	42	9259	51402	29513824
Adrenal insufficiency	13.40	13.33	17	9284	11097	29554129
Melanocytic naevus	13.33	13.33	8	9293	1898	29563328

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Psoriasis	98.74	12.07	99	14110	71604	64412919
Cortisol increased	45.90	12.07	12	14197	429	64484094
Product dose omission issue	45.51	12.07	119	14090	194628	64289895
Seborrhoeic dermatitis	36.11	12.07	14	14195	1812	64482711
Adrenal insufficiency	34.56	12.07	33	14176	22454	64462069
Toxicity to various agents	33.88	12.07	19	14190	363494	64121029
Tarsal tunnel syndrome	30.65	12.07	9	14200	496	64484027
Hypothalamic pituitary adrenal axis suppression	30.60	12.07	8	14201	286	64484237
Purpura senile	30.55	12.07	9	14200	502	64484021
Drug interaction	29.98	12.07	158	14051	361925	64122598
Rhabdomyolysis	28.91	12.07	63	14146	91663	64392860
Eczema	28.58	12.07	34	14175	29686	64454837
Colour vision tests normal	26.91	12.07	4	14205	4	64484519
Impetigo	25.92	12.07	11	14198	1795	64482728
Anaplastic astrocytoma	25.21	12.07	6	14203	145	64484378
Transient aphasia	24.39	12.07	6	14203	167	64484356
Vertigo positional	23.80	12.07	12	14197	2899	64481624
Resorption bone increased	23.25	12.07	9	14200	1159	64483364
Central vision loss	22.69	12.07	4	14205	19	64484504
Therapeutic response unexpected	22.50	12.07	23	14186	16978	64467545
Pneumonia mycoplasmal	22.08	12.07	9	14200	1327	64483196
Swelling of eyelid	20.79	12.07	10	14199	2182	64482341
Vestibular disorder	20.36	12.07	10	14199	2283	64482240
Drug abuse	19.36	12.07	3	14206	132371	64352152
Cortisol free urine decreased	17.44	12.07	3	14206	12	64484511
Vitamin E deficiency	16.43	12.07	3	14206	18	64484505
Dermatitis	16.31	12.07	20	14189	18009	64466514
Infusion related reaction	16.18	12.07	8	14201	164459	64320064
Deafness bilateral	16.12	12.07	8	14201	1868	64482655
Hepatitis fulminant	15.32	12.07	12	14197	6262	64478261
Alcohol intolerance	15.31	12.07	5	14204	393	64484130
Guttate psoriasis	15.27	12.07	5	14204	396	64484127
Polyarteritis nodosa	14.46	12.07	5	14204	468	64484055
Penile oedema	14.41	12.07	4	14205	180	64484343
Hepatotoxicity	14.39	12.07	29	14180	39933	64444590
Blood uric acid decreased	13.47	12.07	6	14203	1100	64483423
Drug clearance increased	13.42	12.07	4	14205	232	64484291
Headache	13.17	12.07	176	14033	529291	63955232
Pathogen resistance	13.14	12.07	15	14194	12528	64471995
Dermatitis atopic	13.05	12.07	9	14200	3867	64480656
Application site swelling	12.97	12.07	5	14204	637	64483886
Psoriatic arthropathy	12.81	12.07	29	14180	43252	64441271
Swelling face	12.62	12.07	35	14174	59131	64425392
Myotonic dystrophy	12.51	12.07	3	14206	75	64484448
Aspergillus test positive	12.49	12.07	5	14204	703	64483820
Muscle fatigue	12.45	12.07	8	14201	3057	64481466
Dermatitis psoriasiform	12.34	12.07	7	14202	2139	64482384
Hyperadrenocorticism	12.27	12.07	4	14205	312	64484211
Hypertrophy	12.15	12.07	5	14204	755	64483768

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Steroid 17-alpha-hydroxylase/17,20 lyase	Enzyme	P05093	CP17A_HUMAN	INHIBITOR	IC50	7.28	WOMBAT-PK	DRUG LABEL
Cytochrome P450 11B1, mitochondrial	Enzyme	P15538	C11B1_HUMAN	INHIBITOR	IC50	6.90	SCIENTIFIC LITERATURE	DRUG LABEL
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		Ki	7	WOMBAT-PK
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Ki	6	WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	6.55	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	4.62	DRUG MATRIX
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.08	DRUG MATRIX
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	4.67	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	5.03	DRUG MATRIX
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	5.46	WOMBAT-PK
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	4.73	DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN				WOMBAT-PK
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	4.84	DRUG MATRIX
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	5.35	DRUG MATRIX
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN		IC50	5.54	CHEMBL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	4.40	CHEMBL
Aromatase	Enzyme	P11511	CP19A_HUMAN		Ki	6.40	CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial	Enzyme	O15528	CP27B_HUMAN		IC50	6.47	CHEMBL
Potassium voltage-gated channel subfamily A member 10	Ion channel	Q16322	KCA10_HUMAN	BLOCKER	IC50	6.30	IUPHAR
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	4.72	CHEMBL
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN		IC50	5.67	DRUG MATRIX
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		app Ki	7.20	WOMBAT-PK
Indoleamine 2,3-dioxygenase 1	Enzyme	P14902	I23O1_HUMAN		IC50	4.60	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	5.58	CHEMBL
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	5.24	DRUG MATRIX
Cytochrome P450 3A5	Enzyme	P20815	CP3A5_HUMAN		IC50	6.92	CHEMBL
1,25-dihydroxyvitamin D(3) 24-hydroxylase, mitochondrial	Enzyme	Q07973	CP24A_HUMAN		IC50	6.51	WOMBAT-PK
Cytochrome P450 21	Enzyme	P08686	CP21A_HUMAN		IC50	5.05	CHEMBL
Sodium/nucleoside cotransporter 1	Transporter	O00337	S28A1_HUMAN		Ki	5.82	DRUG MATRIX
Cytochrome P450 11B2, mitochondrial	Enzyme	P19099	C11B2_HUMAN	INHIBITOR	IC50	7.17	SCIENTIFIC LITERATURE
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	5.13	DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.72	WOMBAT-PK
Lanosterol 14-alpha demethylase	Enzyme		CP51_CANAL	INHIBITOR	IC50	7	WOMBAT-PK	CHEMBL
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.27	DRUG MATRIX
Alpha-1B adrenergic receptor	GPCR		ADA1B_RAT		Ki	4.90	DRUG MATRIX
5-hydroxytryptamine receptor 1B	GPCR		5HT1B_RAT		Ki	5.21	DRUG MATRIX
Membrane-associated progesterone receptor component 1	Membrane receptor		PGRC1_RAT		Ki	5.01	DRUG MATRIX
Alpha-1A adrenergic receptor	GPCR		ADA1A_RAT		IC50	4.45	CHEMBL
Gonadotropin-releasing hormone receptor	GPCR		GNRHR_RAT		Kd	9.66	CHEMBL
Cytochrome P450 11B1	Enzyme		C11B1_BOVIN		IC50	6.82	CHEMBL
Cytochrome P450 11A1	Enzyme		CP11A_RAT		IC50	5.91	CHEMBL
Cytochrome P450 24A1	Enzyme		CP24A_RAT		IC50	4.70	CHEMBL
Cytochrome P450 7A1	Enzyme		CP7A1_RAT		IC50	6.71	CHEMBL
Cytochrome P450 51	Enzyme		CP51A_RAT		Ki	7.19	CHEMBL
Bile salt export pump	Transporter		ABCBB_RAT		IC50	4.81	CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial	Enzyme		CP27B_MOUSE		IC50	6.44	CHEMBL
Cytochrome P450 17A1	Enzyme		CP17A_RAT		IC50	6.69	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	43063-882	TABLET	200 mg	ORAL	ANDA	26 sections
Ketodan	HUMAN PRESCRIPTION DRUG LABEL	1	43538-530	AEROSOL, FOAM	20 mg	TOPICAL	ANDA	28 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	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
Ketoconazole	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5265	CREAM	20 mg	TOPICAL	ANDA	17 sections
Nizoral	HUMAN PRESCRIPTION DRUG LABEL	1	50458-680	SHAMPOO	20 mg	TOPICAL	NDA	20 sections
Ketoconazole	HUMAN PRESCRIPTION DRUG LABEL	1	51407-279	CREAM	20 mg	TOPICAL	ANDA	19 sections
Ketoconazole	HUMAN PRESCRIPTION DRUG LABEL	1	51672-1298	CREAM	20 mg	TOPICAL	ANDA	19 sections
Ketoconazole	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4026	TABLET	200 mg	ORAL	ANDA	26 sections