All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
testosterone reductase inhibitors	973	164656-23-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dutasteride veltride avodart avolve GG745 GG-745	A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA. Molecular weight: 528.54 Formula: C27H30F6N2O2 CLOGP: 4.94 LIPINSKI: 1 HAC: 4 HDO: 2 TPSA: 58.20 ALOGS: -5.77 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Nov. 20, 2001	FDA	GLAXOSMITHKLINE

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
Accidental exposure to product	39.95	38.02	10	153	27395	63461464

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
Drug dispensed to wrong patient	168.02	12.26	45	26613	479	34929794
Conjunctivitis allergic	124.56	12.26	43	26615	1127	34929146
Mycotic allergy	116.82	12.26	35	26623	573	34929700
Spirometry abnormal	114.97	12.26	36	26622	688	34929585
Sleep disorder due to a general medical condition	112.26	12.26	62	26596	5159	34925114
Mite allergy	111.87	12.26	35	26623	667	34929606
Dust allergy	107.03	12.26	36	26622	870	34929403
Antimicrobial susceptibility test resistant	105.33	12.26	29	26629	345	34929928
Orthostatic hypotension	102.20	12.26	112	26546	25807	34904466
Minimum inhibitory concentration	94.69	12.26	23	26635	159	34930114
Therapeutic response delayed	85.98	12.26	28	26630	610	34929663
Urinary retention	80.95	12.26	118	26540	36170	34894103
Breast cancer	79.50	12.26	22	26636	267	34930006
Asthma	78.68	12.26	127	26531	42529	34887744
Wrong patient received product	78.43	12.26	39	26619	2615	34927658
Sopor	74.95	12.26	67	26591	12069	34918204
Gynaecomastia	70.51	12.26	60	26598	10120	34920153
Toxicity to various agents	65.01	12.26	36	26622	200326	34729947
Wheezing	62.78	12.26	113	26545	41289	34888984
Breast tenderness	54.68	12.26	21	26637	750	34929523
Normochromic normocytic anaemia	53.65	12.26	36	26622	4251	34926022
Prostate cancer	49.94	12.26	100	26558	39549	34890724
Product administration error	48.38	12.26	61	26597	16283	34913990
Fall	47.90	12.26	291	26367	202594	34727679
Dysuria	47.55	12.26	79	26579	27073	34903200
Product dispensing error	45.55	12.26	38	26620	6236	34924037
Breast pain	45.23	12.26	22	26636	1406	34928867
Full blood count abnormal	44.98	12.26	63	26595	18605	34911668
Completed suicide	44.81	12.26	10	26648	98158	34832115
Expired product administered	44.09	12.26	29	26629	3312	34926961
Nipple pain	40.80	12.26	18	26640	919	34929354
Wrong product administered	40.17	12.26	33	26625	5301	34924972
Prostatomegaly	40.13	12.26	33	26625	5308	34924965
Product storage error	38.97	12.26	39	26619	8083	34922190
Dyspnoea	38.80	12.26	448	26210	376334	34553939
Erectile dysfunction	37.42	12.26	61	26597	20576	34909697
Foveal degeneration	37.08	12.26	6	26652	0	34930273
Prostatic specific antigen increased	34.56	12.26	49	26609	14631	34915642
Syncope	33.98	12.26	149	26509	91302	34838971
Breast enlargement	33.36	12.26	13	26645	483	34929790
5-alpha-reductase deficiency	32.92	12.26	6	26652	6	34930267
Cardiac failure	32.64	12.26	147	26511	91101	34839172
Asthenia	30.96	12.26	304	26354	244947	34685326
Forced vital capacity decreased	30.89	12.26	14	26644	762	34929511
Tachyarrhythmia	30.74	12.26	24	26634	3584	34926689
Productive cough	30.52	12.26	80	26578	37733	34892540
Vertigo	30.48	12.26	63	26595	25473	34904800
Nodule	29.56	12.26	31	26627	6788	34923485
Subarachnoid haematoma	29.15	12.26	10	26648	257	34930016
Pulmonary function test abnormal	28.15	12.26	20	26638	2590	34927683
Dark circles under eyes	28.03	12.26	7	26651	55	34930218
Drug abuse	26.48	12.26	22	26636	99074	34831199
Drug interaction	26.07	12.26	275	26383	225671	34704602
Ossicle disorder	26.03	12.26	6	26652	32	34930241
Malaise	25.74	12.26	235	26423	185590	34744683
Arteriosclerosis coronary artery	25.53	12.26	39	26619	12446	34917827
Haematuria	25.41	12.26	90	26568	49976	34880297
Obesity	24.62	12.26	39	26619	12839	34917434
Diffuse idiopathic skeletal hyperostosis	24.16	12.26	6	26652	46	34930227
Hyponatraemic syndrome	23.79	12.26	8	26650	193	34930080
Cerebral haematoma	23.70	12.26	23	26635	4592	34925681
Disorganised speech	22.96	12.26	12	26646	893	34929380
Breast induration	22.48	12.26	4	26654	3	34930270
Eye haematoma	22.30	12.26	6	26652	65	34930208
Rectal haemorrhage	21.85	12.26	74	26584	40175	34890098
Multiple organ dysfunction syndrome	21.71	12.26	16	26642	76550	34853723
Gait disturbance	21.22	12.26	124	26534	85016	34845257
Product dose omission issue	20.93	12.26	37	26621	119674	34810599
Breast mass	20.69	12.26	10	26648	630	34929643
Pollakiuria	20.56	12.26	46	26612	19628	34910645
Presyncope	20.41	12.26	45	26613	19014	34911259
Myoclonic epilepsy	20.21	12.26	12	26646	1145	34929128
FEV1/FVC ratio decreased	19.81	12.26	6	26652	102	34930171
Subdural haematoma	19.41	12.26	46	26612	20375	34909898
Semen volume decreased	19.34	12.26	8	26650	348	34929925
Sepsis	19.23	12.26	64	26594	166497	34763776
Invasive ductal breast carcinoma	19.13	12.26	5	26653	48	34930225
Genitalia external ambiguous	18.95	12.26	7	26651	224	34930049
Loss of personal independence in daily activities	18.90	12.26	62	26596	33117	34897156
Intraventricular haemorrhage	18.89	12.26	18	26640	3513	34926760
Drug ineffective	18.77	12.26	241	26417	456510	34473763
Lower urinary tract symptoms	18.66	12.26	7	26651	234	34930039
Obstructive airways disorder	18.22	12.26	38	26620	15456	34914817
Breast cancer male	18.18	12.26	8	26650	406	34929867
Procedural haemorrhage	18.08	12.26	15	26643	2442	34927831
Pemphigoid	17.62	12.26	27	26631	8639	34921634
Autonomic nervous system imbalance	17.59	12.26	15	26643	2536	34927737
Death	17.48	12.26	207	26451	397842	34532431
Occupational exposure to air contaminants	17.35	12.26	6	26652	158	34930115
Urine flow decreased	16.91	12.26	11	26647	1233	34929040
Pain	16.61	12.26	90	26568	204585	34725688
Asthma-chronic obstructive pulmonary disease overlap syndrome	16.57	12.26	11	26647	1276	34928997
Loss of consciousness	16.04	12.26	113	26545	82554	34847719
Nausea	16.00	12.26	174	26484	339734	34590539
Hyperkalaemia	15.97	12.26	99	26559	69290	34860983
Wrong strength	15.57	12.26	5	26653	104	34930169
Tongue oedema	15.51	12.26	15	26643	2982	34927291
Respiratory symptom	15.41	12.26	12	26646	1785	34928488
Foetal exposure during pregnancy	15.27	12.26	5	26653	38096	34892177
Urinary tract infection	15.19	12.26	113	26545	83968	34846305
Hepatocellular injury	14.96	12.26	44	26614	22167	34908106
Haemorrhage	14.92	12.26	78	26580	51292	34878981
Libido decreased	14.65	12.26	18	26640	4678	34925595
Atrial fibrillation	14.56	12.26	150	26508	122243	34808030
Prostatic haemorrhage	14.50	12.26	6	26652	261	34930012
Treatment failure	14.25	12.26	9	26649	46688	34883585
Medical device site haemorrhage	14.24	12.26	5	26653	138	34930135
Febrile neutropenia	14.18	12.26	55	26603	136794	34793479
Off label use	14.18	12.26	230	26428	419294	34510979
Abnormal sleep-related event	13.93	12.26	7	26651	480	34929793
Hypoglycaemia	13.88	12.26	80	26578	54560	34875713
Cardio-respiratory arrest	13.88	12.26	13	26645	55260	34875013
Blood immunoglobulin E increased	13.66	12.26	13	26645	2533	34927740
Arteriosclerosis	13.66	12.26	29	26629	11939	34918334
Product use in unapproved indication	13.65	12.26	45	26613	117454	34812819
Dyspnoea exertional	13.47	12.26	67	26591	43212	34887061
Body mass index increased	13.38	12.26	9	26649	1066	34929207
Cough	13.38	12.26	174	26484	149966	34780307
Vascular dementia	13.36	12.26	7	26651	524	34929749
Blood gases abnormal	13.25	12.26	6	26652	326	34929947
Blood pressure systolic increased	13.17	12.26	43	26615	22909	34907364
Lactic acidosis	13.16	12.26	57	26601	34715	34895558
Benign prostatic hyperplasia	13.08	12.26	32	26626	14463	34915810
Forced expiratory volume decreased	12.89	12.26	14	26644	3189	34927084
Breast disorder male	12.86	12.26	3	26655	17	34930256
Hyperkeratosis	12.73	12.26	15	26643	3734	34926539
Testicular pain	12.55	12.26	13	26645	2805	34927468
Sputum increased	12.53	12.26	12	26646	2358	34927915
Respiratory arrest	12.50	12.26	3	26655	28040	34902233
Lung hyperinflation	12.33	12.26	8	26650	892	34929381

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
Conjunctivitis allergic	142.68	13.08	41	21774	1679	79720894
Spirometry abnormal	131.68	13.08	34	21781	925	79721648
Antimicrobial susceptibility test resistant	128.23	13.08	28	21787	360	79722213
Mite allergy	123.29	13.08	34	21781	1196	79721377
Drug dispensed to wrong patient	121.58	13.08	30	21785	676	79721897
Dust allergy	120.23	13.08	35	21780	1501	79721072
Minimum inhibitory concentration	118.43	13.08	23	21792	157	79722416
Mycotic allergy	116.20	13.08	34	21781	1485	79721088
Sleep disorder due to a general medical condition	107.89	13.08	60	21755	14217	79708356
Orthostatic hypotension	102.84	13.08	100	21715	56064	79666509
Therapeutic response delayed	93.73	13.08	27	21788	1115	79721458
Urinary retention	77.01	13.08	86	21729	56544	79666029
Sopor	76.38	13.08	67	21748	32943	79689630
Prostate cancer	75.93	13.08	67	21748	33201	79689372
Wrong patient received product	69.49	13.08	31	21784	4587	79717986
Drug interaction	69.40	13.08	260	21555	414923	79307650
Gynaecomastia	62.78	13.08	34	21781	7647	79714926
Normochromic normocytic anaemia	62.59	13.08	34	21781	7693	79714880
Cardiac failure	56.08	13.08	128	21687	154714	79567859
Wheezing	54.49	13.08	107	21708	116557	79606016
Asthma	53.79	13.08	116	21699	134979	79587594
Syncope	52.87	13.08	137	21678	179312	79543261
Haematuria	51.77	13.08	78	21737	68758	79653815
Expired product administered	51.55	13.08	29	21786	7022	79715551
Erectile dysfunction	49.24	13.08	37	21778	14627	79707946
Pain	48.10	13.08	74	21741	703728	79018845
Product dispensing error	47.98	13.08	35	21780	13228	79709345
Full blood count abnormal	47.52	13.08	57	21758	40417	79682156
Wrong product administered	47.45	13.08	30	21785	8982	79713591
Fall	47.28	13.08	260	21555	487369	79235204
Toxicity to various agents	45.09	13.08	30	21785	421510	79301063
Arteriosclerosis coronary artery	44.94	13.08	38	21777	17778	79704795
Completed suicide	44.48	13.08	7	21808	245760	79476813
Product administration error	42.66	13.08	48	21767	31798	79690775
Nipple pain	42.43	13.08	14	21801	912	79721661
Acute kidney injury	41.98	13.08	264	21551	519140	79203433
Prostatomegaly	41.84	13.08	20	21795	3463	79719110
Hyperkalaemia	40.77	13.08	94	21721	114304	79608269
Dyspnoea	39.94	13.08	383	21432	856642	78865931
Atrial fibrillation	39.04	13.08	131	21684	197755	79524818
Asthenia	38.83	13.08	256	21559	511433	79211140
Tachyarrhythmia	38.73	13.08	24	21791	6938	79715635
Subarachnoid haematoma	38.28	13.08	10	21805	285	79722288
Prostatic specific antigen increased	36.65	13.08	27	21788	10359	79712214
Pulmonary function test abnormal	35.70	13.08	19	21796	4125	79718448
Nausea	34.54	13.08	140	21675	957056	78765517
Productive cough	34.17	13.08	75	21740	88256	79634317
Drug intolerance	33.75	13.08	15	21800	264104	79458469
Cerebral haematoma	33.45	13.08	23	21792	7919	79714654
Subdural haematoma	33.24	13.08	42	21773	31392	79691181
Dysuria	33.11	13.08	54	21761	50897	79671676
Treatment failure	32.86	13.08	4	21811	170482	79552091
Ossicle disorder	32.16	13.08	6	21809	32	79722541
Rectal haemorrhage	32.06	13.08	67	21748	76233	79646340
Alopecia	31.40	13.08	12	21803	231343	79491230
Forced vital capacity decreased	30.45	13.08	13	21802	1730	79720843
Drug ineffective	30.31	13.08	173	21642	1080740	78641833
Breast tenderness	30.25	13.08	14	21801	2254	79720319
Joint swelling	30.23	13.08	21	21794	288625	79433948
Intraventricular haemorrhage	30.14	13.08	18	21797	4869	79717704
Product storage error	29.88	13.08	29	21786	16197	79706376
Diffuse idiopathic skeletal hyperostosis	29.53	13.08	6	21809	53	79722520
Semen volume decreased	28.42	13.08	6	21809	65	79722508
Vertigo	27.11	13.08	59	21756	69023	79653550
Obstructive airways disorder	27.06	13.08	38	21777	31421	79691152
Hypoglycaemia	26.31	13.08	74	21741	101520	79621053
Pemphigoid	25.66	13.08	26	21789	15289	79707284
Contraindicated product administered	25.30	13.08	6	21809	157532	79565041
Lactic acidosis	25.26	13.08	58	21757	70301	79652272
Disorganised speech	24.96	13.08	12	21803	2105	79720468
Therapeutic product effect decreased	24.86	13.08	7	21808	163856	79558717
Arteriosclerosis	23.61	13.08	27	21788	18200	79704373
Occupational exposure to air contaminants	23.42	13.08	6	21809	158	79722415
Eye haematoma	23.28	13.08	6	21809	162	79722411
Infusion related reaction	22.49	13.08	18	21797	230219	79492354
Dyspnoea exertional	22.13	13.08	63	21752	87010	79635563
Presyncope	22.06	13.08	40	21775	41014	79681559
Lower urinary tract symptoms	21.92	13.08	6	21809	205	79722368
Benign prostatic hyperplasia	21.85	13.08	21	21794	11591	79710982
Breast enlargement	21.79	13.08	10	21805	1579	79720994
Gait disturbance	21.63	13.08	113	21702	207393	79515180
Nodule	21.62	13.08	29	21786	22965	79699608
Breast pain	21.61	13.08	18	21797	8247	79714326
Hepatocellular injury	21.41	13.08	43	21772	47550	79675023
FEV1/FVC ratio decreased	21.36	13.08	6	21809	226	79722347
Hyponatraemic syndrome	21.21	13.08	8	21807	772	79721801
Obesity	21.18	13.08	36	21779	35089	79687484
Chronic obstructive pulmonary disease	20.93	13.08	61	21754	85358	79637215
Dark circles under eyes	20.87	13.08	7	21808	480	79722093
Procedural haemorrhage	20.70	13.08	14	21801	4692	79717881
Haemorrhage	20.37	13.08	63	21752	91055	79631518
Pulmonary embolism	19.66	13.08	96	21719	171558	79551015
Loss of consciousness	19.29	13.08	94	21721	167849	79554724
Hand deformity	18.70	13.08	3	21812	103916	79618657
Arthralgia	18.50	13.08	87	21728	571716	79150857
Pollakiuria	18.35	13.08	35	21780	37282	79685291
Rheumatoid arthritis	18.31	13.08	18	21797	208452	79514121
Headache	18.05	13.08	105	21710	653667	79068906
Medical device site haemorrhage	17.96	13.08	5	21810	182	79722391
Wrong strength	17.91	13.08	5	21810	184	79722389
Asthma-chronic obstructive pulmonary disease overlap syndrome	17.65	13.08	11	21804	3210	79719363
Penile abscess	17.46	13.08	3	21812	9	79722564
Breast disorder male	17.22	13.08	3	21812	10	79722563
Testicular swelling	17.21	13.08	8	21807	1302	79721271
Epididymitis	17.05	13.08	9	21806	1921	79720652
Body mass index increased	17.04	13.08	9	21806	1924	79720649
Inferior vena cava dilatation	16.90	13.08	7	21808	864	79721709
Thrombosis	16.85	13.08	56	21759	84044	79638529
Vascular dementia	16.84	13.08	7	21808	872	79721701
Abnormal sleep-related event	16.76	13.08	7	21808	882	79721691
Pulmonary interstitial emphysema syndrome	16.56	13.08	6	21809	517	79722056
Hypoaesthesia	16.31	13.08	15	21800	179337	79543236
Left ventricular dysfunction	16.08	13.08	23	21792	19338	79703235
Renal failure	16.07	13.08	102	21713	200866	79521707
Respiratory symptom	15.89	13.08	12	21803	4779	79717794
Blood immunoglobulin E increased	15.77	13.08	13	21802	5869	79716704
Bronchial hyperreactivity	15.70	13.08	10	21805	3030	79719543
Blood testosterone increased	15.63	13.08	7	21808	1045	79721528
Facial bones fracture	15.26	13.08	12	21803	5070	79717503
Urine flow decreased	15.20	13.08	7	21808	1114	79721459
Cerebral haemorrhage	14.92	13.08	42	21773	57631	79664942
Brain stem haematoma	14.90	13.08	4	21811	127	79722446
Clostridium test positive	14.72	13.08	13	21802	6441	79716132
Violence-related symptom	14.61	13.08	6	21809	725	79721848
Malaise	14.60	13.08	201	21614	489668	79232905
Hyperkeratosis	14.49	13.08	14	21801	7776	79714797
Hypoxia	14.24	13.08	61	21754	103182	79619391
Product dose omission issue	14.16	13.08	29	21786	247508	79475065
Sputum increased	14.08	13.08	11	21804	4602	79717971
Arthropathy	13.67	13.08	17	21798	177094	79545479
Toxic skin eruption	13.64	13.08	23	21792	22270	79700303
Tongue oedema	13.63	13.08	13	21802	7104	79715469
Depression	13.62	13.08	24	21791	216766	79505807
Bronchiectasis	13.57	13.08	23	21792	22363	79700210
Vomiting	13.46	13.08	117	21698	665711	79056862
Peripheral sensorimotor neuropathy	13.35	13.08	9	21806	3001	79719572
Breast induration	13.31	13.08	3	21812	45	79722528

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G04CA52	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
ATC	G04CB02	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Testosterone-5-alpha reductase inhibitors
FDA MoA	N0000000126	5-alpha Reductase Inhibitors
MeSH PA	D058891	5-alpha Reductase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D065088	Steroid Synthesis Inhibitors
FDA EPC	N0000175836	5-alpha Reductase Inhibitor

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

Disease	Relation	SNOMED_ID	DOID
Benign prostatic hyperplasia	indication	266569009
Priapism	contraindication	6273006	DOID:9286
Orthostatic hypotension	contraindication	28651003
Oligozoospermia	contraindication	88311004
Cataract surgery	contraindication	110473004
Disease of liver	contraindication	235856003	DOID:409
Syncope	contraindication	271594007
Pregnancy, function	contraindication	289908002
Dizziness	contraindication	404640003
Breastfeeding (mother)	contraindication	413712001
Intraoperative floppy iris syndrome	contraindication	418801006
High-Grade Prostate Cancer	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.41	acidic
pKa2	13.26	acidic

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])	Mechanism action	Bioact source	MoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme	P31213	S5A2_HUMAN	INHIBITOR	IC50	9.20		WOMBAT-PK	CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme	P18405	S5A1_HUMAN	INHIBITOR	IC50	8.49		WOMBAT-PK	CHEMBL
Glycine receptor subunit alpha-1	Ion channel	P23415	GLRA1_HUMAN		EC50	6.48		CHEMBL

External reference:

ID	Source
4021371	VUID
N0000148790	NUI
D03820	KEGG_DRUG
4021371	VANDF
C0754659	UMLSCUI
CHEMBL1200969	ChEMBL_ID
D000068538	MESH_DESCRIPTOR_UI
DB01126	DRUGBANK_ID
7457	IUPHAR_LIGAND_ID
7586	INN_ID
O0J6XJN02I	UNII
6918296	PUBCHEM_CID
228790	RXNORM
16302	MMSL
228246	MMSL
42738	MMSL
d04788	MMSL
009824	NDDF
385570006	SNOMEDCT_US
385572003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1438	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
AVODART	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0712	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	NDA	27 sections
JALYN	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0809	CAPSULE	0.50 mg	ORAL	NDA	29 sections
JALYN	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0809	CAPSULE	0.50 mg	ORAL	NDA	29 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0173-7077	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	Export only	2 sections
Dutasteride and Tamsulosin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	10370-280	CAPSULE	0.50 mg	ORAL	ANDA	28 sections
Dutasteride and Tamsulosin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	10370-280	CAPSULE	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	Human Prescription Drug Label	1	25000-011	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	29 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	31722-131	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-549	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4010	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	51013-190	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	51407-157	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	51407-157	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	53345-037	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Avodart	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5114	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	NDA	27 sections
JALYN	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6328	CAPSULE	0.50 mg	ORAL	NDA	28 sections
Dutasteride	Human Prescription Drug Label	1	59651-021	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	62112-8068	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	27 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1222	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1222	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1222	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1223	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1223	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1223	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8207	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8207	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	64380-763	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	25 sections
DUTASTERIDE	HUMAN PRESCRIPTION DRUG LABEL	1	64980-224	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	26 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	65162-750	CAPSULE	0.50 mg	ORAL	ANDA	18 sections