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

Stem definition	Drug id	CAS RN
renin inhibitors	119	173334-57-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: aliskiren rasilez tekturna aliskiren hemifumarate aliskiren fumarate SPP100	Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS). Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other RAAS components, e.g., ACE or non-ACE pathways, is not known. Molecular weight: 551.77 Formula: C30H53N3O6 CLOGP: 3.51 LIPINSKI: 1 HAC: 9 HDO: 4 TPSA: 146.13 ALOGS: -5.42 ROTB: 19 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

aliskiren
rasilez
tekturna
aliskiren hemifumarate
aliskiren fumarate
SPP100

Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS). Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other RAAS components, e.g., ACE or non-ACE pathways, is not known.

Molecular weight: 551.77
Formula: C30H53N3O6
CLOGP: 3.51
LIPINSKI: 1
HAC: 9
HDO: 4
TPSA: 146.13
ALOGS: -5.42
ROTB: 19

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.15	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	7.77 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	25 %	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	2.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Aug. 22, 2007	EMA	Noden Pharma DAC
March 5, 2007	FDA	NOVARTIS

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
Neurologic neglect syndrome	556.63	23.99	119	9474	2602	63476827
Carotid artery thrombosis	553.50	23.99	119	9474	2675	63476754
Personality disorder	551.65	23.99	136	9457	5675	63473754
Adjustment disorder	499.76	23.99	112	9481	3066	63476363
Hemiplegia	492.47	23.99	137	9456	9186	63470243
Affect lability	468.21	23.99	137	9456	11014	63468415
Sensory loss	408.80	23.99	121	9472	10117	63469312
Motor dysfunction	394.22	23.99	119	9474	10642	63468787
Muscle spasticity	374.25	23.99	136	9457	21658	63457771
Coordination abnormal	369.36	23.99	120	9473	13653	63465776
Hemiparesis	350.88	23.99	132	9461	23150	63456279
Aphasia	339.55	23.99	142	9451	32858	63446571
Eating disorder	312.82	23.99	115	9478	18901	63460528
Cerebrovascular accident	291.79	23.99	189	9404	107835	63371594
Dysarthria	282.81	23.99	135	9458	42576	63436853
Dysphagia	244.02	23.99	157	9436	88428	63391001
Blood pressure inadequately controlled	177.69	23.99	54	9539	4924	63474505
Muscular weakness	177.14	23.99	147	9446	122206	63357223
Skin haemorrhage	140.28	23.99	54	9539	10040	63469389
Anxiety	119.04	23.99	155	9438	217386	63262043
Angioedema	105.41	23.99	74	9519	47891	63431538
Respiratory tract congestion	104.75	23.99	52	9541	17780	63461649
Sinus congestion	103.95	23.99	52	9541	18071	63461358
Sneezing	103.69	23.99	52	9541	18166	63461263
Confusional state	103.11	23.99	151	9442	236229	63243200
Diabetes mellitus inadequate control	91.48	23.99	45	9548	15081	63464348
Conjoined twins	91.02	23.99	18	9575	262	63479167
Sinus disorder	89.12	23.99	52	9541	24501	63454928
Blood pressure increased	80.13	23.99	110	9483	161952	63317477
Impaired work ability	76.92	23.99	42	9551	17433	63461996
Skin exfoliation	73.30	23.99	57	9536	43045	63436384
Arterial occlusive disease	72.64	23.99	29	9564	5929	63473500
Off label use	69.14	23.99	10	9583	674452	62804977
Intestinal malrotation	68.55	23.99	15	9578	365	63479064
Concomitant disease progression	67.05	23.99	21	9572	2113	63477316
Congenital bladder anomaly	66.96	23.99	13	9580	171	63479258
Urachal abnormality	66.40	23.99	13	9580	179	63479250
Persistent cloaca	65.55	23.99	13	9580	192	63479237
Cystitis	65.10	23.99	59	9534	54932	63424497
Gangrene	65.05	23.99	27	9566	6096	63473333
Angina pectoris	62.80	23.99	45	9548	30033	63449396
Asthenia	60.97	23.99	160	9433	383444	63095985
Fall	59.68	23.99	161	9432	392173	63087256
Influenza like illness	55.38	23.99	59	9534	66765	63412664
Exercise tolerance decreased	50.94	23.99	22	9571	5475	63473954
Multiple drug therapy	48.84	23.99	19	9574	3627	63475802
Rhinorrhoea	47.57	23.99	54	9539	65523	63413906
Hyperkalaemia	45.15	23.99	48	9545	54155	63425274
Blood creatinine increased	39.44	23.99	57	9536	87787	63391642
Anal prolapse	36.49	23.99	7	9586	86	63479343
Psoriasis	35.55	23.99	54	9539	86903	63392526
Drug intolerance	32.91	23.99	4	9589	308657	63170772
Influenza	30.43	23.99	57	9536	108665	63370764
Toxicity to various agents	26.86	23.99	3	9590	247247	63232182
Arthralgia	26.81	23.99	28	9565	569682	62909747
Gastric disorder	25.78	23.99	30	9563	37339	63442090
Infusion related reaction	24.25	23.99	4	9589	245517	63233912

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
Concomitant disease progression	291.45	20.25	68	4769	2450	34949644
Blood creatinine increased	106.76	20.25	95	4742	94881	34857213
Hyperkalaemia	89.22	20.25	75	4762	69314	34882780
Urine albumin/creatinine ratio increased	52.04	20.25	11	4826	248	34951846
Renal impairment	50.98	20.25	64	4773	94449	34857645
Chronic kidney disease	49.72	20.25	43	4794	41167	34910927
Blood pressure inadequately controlled	48.68	20.25	17	4820	2623	34949471
Angina pectoris	42.50	20.25	35	4802	31328	34920766
Blood potassium increased	42.05	20.25	27	4810	16468	34935626
Blood pressure increased	40.25	20.25	55	4782	88047	34864047
Angioedema	35.29	20.25	34	4803	37340	34914754
Bundle branch block left	35.24	20.25	17	4820	5962	34946132
Disease progression	33.07	20.25	56	4781	108021	34844073
Diabetic nephropathy	32.80	20.25	12	4825	2116	34949978
Hypotension	32.63	20.25	85	4752	221564	34730530
Off label use	32.52	20.25	9	4828	419515	34532579
Glycosylated haemoglobin increased	32.48	20.25	20	4817	11340	34940754
Oedema peripheral	30.14	20.25	57	4780	119755	34832339
Post procedural haematoma	28.80	20.25	10	4827	1516	34950578
Cardiac failure acute	28.67	20.25	18	4819	10552	34941542
Blood urea increased	27.49	20.25	27	4810	30337	34921757
Acute pulmonary oedema	26.42	20.25	15	4822	7328	34944766
Dyspnoea	26.15	20.25	112	4725	376670	34575424
Bundle branch block right	26.09	20.25	15	4822	7501	34944593
Orthopnoea	25.59	20.25	13	4824	5090	34947004
Syncope	24.85	20.25	45	4792	91406	34860688
Renal failure	24.44	20.25	55	4782	130502	34821592
Cardiac failure chronic	22.85	20.25	14	4823	7865	34944229
Defect conduction intraventricular	22.61	20.25	6	4831	366	34951728
Oedema	21.52	20.25	29	4808	45712	34906382
Atrioventricular block first degree	20.73	20.25	12	4825	6080	34946014
Myocardial ischaemia	20.64	20.25	18	4819	17390	34934704
Cerebral arteriosclerosis	20.48	20.25	6	4831	526	34951568

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
Neurologic neglect syndrome	549.65	22.00	118	11275	2789	79730206
Carotid artery thrombosis	549.51	22.00	119	11274	2934	79730061
Personality disorder	546.44	22.00	135	11258	6011	79726984
Adjustment disorder	474.97	22.00	111	11282	3889	79729106
Affect lability	465.43	22.00	135	11258	11124	79721871
Hemiplegia	427.77	22.00	135	11258	14804	79718191
Muscle spasticity	379.70	22.00	135	11258	21340	79711655
Sensory loss	374.42	22.00	118	11275	12873	79720122
Motor dysfunction	359.81	22.00	118	11275	14615	79718380
Coordination abnormal	348.91	22.00	120	11273	17192	79715803
Concomitant disease progression	312.19	22.00	77	11316	3396	79729599
Eating disorder	309.50	22.00	115	11278	20582	79712413
Hemiparesis	307.16	22.00	131	11262	33602	79699393
Aphasia	296.54	22.00	141	11252	46591	79686404
Dysarthria	239.35	22.00	138	11255	67484	79665511
Dysphagia	219.60	22.00	163	11230	121973	79611022
Cerebrovascular accident	209.65	22.00	175	11218	155117	79577878
Blood pressure inadequately controlled	156.89	22.00	51	11342	6126	79726869
Muscular weakness	143.98	22.00	144	11249	160585	79572410
Skin haemorrhage	123.93	22.00	51	11342	11930	79721065
Anxiety	103.68	22.00	151	11242	248361	79484634
Sneezing	102.62	22.00	52	11341	19631	79713364
Sinus congestion	99.19	22.00	51	11342	19845	79713150
Respiratory tract congestion	99.05	22.00	51	11342	19903	79713092
Angioedema	94.84	22.00	82	11311	75953	79657042
Sinus disorder	93.36	22.00	51	11342	22413	79710582
Hyperkalaemia	90.59	22.00	96	11297	114302	79618693
Off label use	80.71	22.00	16	11377	907199	78825796
Angina pectoris	75.27	22.00	61	11332	51671	79681324
Impaired work ability	74.44	22.00	42	11351	19639	79713356
Confusional state	72.68	22.00	148	11245	317849	79415146
Diabetes mellitus inadequate control	68.81	22.00	43	11350	24221	79708774
Arterial occlusive disease	64.41	22.00	29	11364	8427	79724568
Blood creatinine increased	62.80	22.00	93	11300	154964	79578031
Blood pressure increased	60.10	22.00	108	11285	211252	79521743
Cystitis	59.99	22.00	54	11339	52678	79680317
Skin exfoliation	57.95	22.00	54	11339	55046	79677949
Gangrene	56.62	22.00	27	11366	8937	79724058
Asthenia	51.32	22.00	175	11218	511514	79221481
Influenza like illness	51.17	22.00	57	11336	71650	79661345
Fall	44.75	22.00	162	11231	487467	79245528
Multiple drug therapy	44.35	22.00	18	11375	4060	79728935
Renal impairment	42.75	22.00	79	11314	157704	79575291
Rhinorrhoea	41.92	22.00	53	11340	76021	79656974
Diabetic nephropathy	39.03	22.00	15	11378	2932	79730063
Exercise tolerance decreased	38.80	22.00	21	11372	9050	79723945
Toxicity to various agents	38.29	22.00	7	11386	421533	79311462
Anal prolapse	38.02	22.00	7	11386	72	79732923
Chronic kidney disease	36.30	22.00	46	11347	66108	79666887
Oedema peripheral	33.27	22.00	95	11298	252193	79480802
Psoriasis	32.37	22.00	51	11342	89536	79643459
Condition aggravated	28.87	22.00	18	11375	501106	79231889
Neutropenia	27.85	22.00	4	11389	287706	79445289
Renal failure	26.79	22.00	76	11317	200892	79532103
Gastric disorder	25.40	22.00	29	11364	37404	79695591
Pharyngeal oedema	25.38	22.00	20	11373	16252	79716743
Influenza	24.55	22.00	56	11337	129550	79603445
Bundle branch block left	24.36	22.00	17	11376	11496	79721499
Post procedural haematoma	23.91	22.00	10	11383	2432	79730563
Rectocele	23.62	22.00	7	11386	618	79732377
Glycosylated haemoglobin increased	22.44	22.00	20	11373	19240	79713755

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C09DX02	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C09XA02	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Renin-inhibitors
ATC	C09XA52	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Renin-inhibitors
ATC	C09XA53	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Renin-inhibitors
ATC	C09XA54	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Renin-inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D011480	Protease Inhibitors
MeSH PA	D000092502	Renin Inhibitors
FDA MoA	N0000175899	Renin Inhibitors
FDA EPC	N0000175900	Renin Inhibitor
CHEBI has role	CHEBI:35674	antihypertensive drugs

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Secondary angle-closure glaucoma	contraindication	21571006
Hypovolemia	contraindication	28560003
Obstruction of bile duct	contraindication	30144000
Dehydration	contraindication	34095006
Hyperuricemia	contraindication	35885006	DOID:1920
Angioedema	contraindication	41291007	DOID:1558
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Sympathectomy	contraindication	57071006
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Hypochloremic alkalosis	contraindication	70134007
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Chronic idiopathic constipation	contraindication	82934008
Hyponatremia	contraindication	89627008
Gout	contraindication	90560007	DOID:13189
Hypomagnesemia	contraindication	190855004
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Neonatal hyperbilirubinemia	contraindication	281610001
Pregnancy, function	contraindication	289908002
Renal artery stenosis	contraindication	302233006
Neutropenic disorder	contraindication	303011007	DOID:1227
Azotemia	contraindication	445009001
Severe Aortic Valve Stenosis	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	12.53	acidic
pKa2	9.2	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
Renin	Enzyme	P00797	RENI_HUMAN	INHIBITOR	IC50	9.22	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Km	5.68	WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		Km	4.61	WOMBAT-PK
Renin	Enzyme		RENI_CALJA		IC50	8.70	CHEMBL
Renin	Enzyme		RENI_MACFA		IC50	8.10	CHEMBL
Renin	Enzyme		RENI_RAT		IC50	7.10	CHEMBL
Renin-1	Enzyme		RENI1_MOUSE		IC50	8.35	CHEMBL
Renin	Enzyme		Q7M3D2_RABIT		IC50	7.96	CHEMBL
Protease	Enzyme		Q9YQ12_9HIV1		Ki	7.12	CHEMBL
Renin	Enzyme		RENI_MACMU		IC50	8.92	CHEMBL

External reference:

ID	Source
4025960	VUID
N0000179765	NUI
D03208	KEGG_DRUG
173334-58-2	SECONDARY_CAS_RN
325646	RXNORM
C1120110	UMLSCUI
CHEBI:601027	CHEBI
C41	PDB_CHEM_ID
CHEMBL1639	ChEMBL_ID
CHEMBL3545059	ChEMBL_ID
CHEMBL1667	ChEMBL_ID
DB09026	DRUGBANK_ID
C446481	MESH_SUPPLEMENTAL_RECORD_UI
4812	IUPHAR_LIGAND_ID
7992	INN_ID
502FWN4Q32	UNII
5493444	PUBCHEM_CID
425981005	SNOMEDCT_US
426725002	SNOMEDCT_US
427002003	SNOMEDCT_US
4025960	VANDF
4030489	VANDF
108166	MMSL
23512	MMSL
310257	MMSL
34310	MMSL
d06665	MMSL
011991	NDDF
011995	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ALISKIREN	HUMAN PRESCRIPTION DRUG LABEL	1	49884-424	TABLET, FILM COATED	150 mg	ORAL	ANDA	29 sections
ALISKIREN	HUMAN PRESCRIPTION DRUG LABEL	1	49884-425	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2985	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2985	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5772	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6041	TABLET, FILM COATED	150 mg	ORAL	NDA	28 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6042	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6103	TABLET, FILM COATED	300 mg	ORAL	NDA	28 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6194	TABLET, FILM COATED	300 mg	ORAL	NDA	28 sections
Aliskiren	HUMAN PRESCRIPTION DRUG LABEL	1	66993-141	TABLET, FILM COATED	150 mg	ORAL	NDA authorized generic	28 sections
Aliskiren	HUMAN PRESCRIPTION DRUG LABEL	1	66993-141	TABLET, FILM COATED	150 mg	ORAL	NDA authorized generic	28 sections
Aliskiren	HUMAN PRESCRIPTION DRUG LABEL	1	66993-142	TABLET, FILM COATED	300 mg	ORAL	NDA authorized generic	28 sections
Aliskiren	HUMAN PRESCRIPTION DRUG LABEL	1	66993-142	TABLET, FILM COATED	300 mg	ORAL	NDA authorized generic	28 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-112	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-112	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-125	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-125	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	70839-150	TABLET, FILM COATED	150 mg	ORAL	NDA	28 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	70839-150	TABLET, FILM COATED	150 mg	ORAL	NDA	28 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	70839-300	TABLET, FILM COATED	300 mg	ORAL	NDA	28 sections
Tekturna	HUMAN PRESCRIPTION DRUG LABEL	1	70839-300	TABLET, FILM COATED	300 mg	ORAL	NDA	28 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-312	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-312	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-325	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Tekturna HCT	HUMAN PRESCRIPTION DRUG LABEL	2	70839-325	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections