olmesartan medoxomil Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic)	1985	144689-63-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: olmesartan medoxomil olmetec CS-866 CS866	Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Molecular weight: 558.60 Formula: C29H30N6O6 CLOGP: 2.66 LIPINSKI: 2 HAC: 12 HDO: 2 TPSA: 154.34 ALOGS: -4.88 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

olmesartan medoxomil
olmetec
CS-866
CS866

Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle.

Molecular weight: 558.60
Formula: C29H30N6O6
CLOGP: 2.66
LIPINSKI: 2
HAC: 12
HDO: 2
TPSA: 154.34
ALOGS: -4.88
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	2 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.02 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	26 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
April 25, 2002	FDA	DAIICHI SANKYO

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
Malabsorption	460.26	10.33	156	37710	3627	46644569
Sprue-like enteropathy	452.12	10.33	98	37768	345	46647851
Intestinal villi atrophy	147.54	10.33	33	37833	139	46648057
Acute kidney injury	146.63	10.33	472	37394	235383	46412813
Hyperkalaemia	100.04	10.33	161	37705	50548	46597648
Hyponatraemia	98.64	10.33	239	37627	101093	46547103
Dehydration	79.53	10.33	297	37569	159243	46488953
Blood pressure increased	70.93	10.33	245	37621	126421	46521775
Renal failure	59.52	10.33	215	37651	113379	46534817
Completed suicide	56.18	10.33	24	37842	145896	46502300
Coeliac disease	55.02	10.33	46	37820	7115	46641081
Hypertensive crisis	54.33	10.33	61	37805	13554	46634642
Colitis microscopic	54.32	10.33	44	37822	6512	46641684
Drug ineffective	52.50	10.33	329	37537	677509	45970687
Hypertension	51.42	10.33	303	37563	196053	46452143
Diarrhoea	48.64	10.33	678	37188	558924	46089272
Dizziness	47.81	10.33	453	37413	339961	46308235
Treatment failure	45.34	10.33	10	37856	93077	46555119
Device related thrombosis	44.04	10.33	21	37845	1206	46646990
Rheumatoid arthritis	43.80	10.33	80	37786	240135	46408061
Bradycardia	42.21	10.33	134	37732	66164	46582032
Death	40.68	10.33	138	37728	335410	46312786
Blood urea increased	40.09	10.33	73	37793	25279	46622917
Metabolic acidosis	39.32	10.33	93	37773	38687	46609509
Toxicity to various agents	37.29	10.33	72	37794	211694	46436502
Gallbladder polyp	36.54	10.33	16	37850	753	46647443
Hypertensive emergency	35.80	10.33	20	37846	1598	46646598
Pancreatic toxicity	32.66	10.33	7	37859	23	46648173
Renal impairment	32.55	10.33	133	37733	74239	46573957
Maternal exposure during pregnancy	31.97	10.33	22	37844	102527	46545669
Cerebral infarction	31.66	10.33	63	37803	23303	46624893
Syncope	31.55	10.33	168	37698	104635	46543561
Blood pressure inadequately controlled	31.18	10.33	27	37839	4379	46643817
Infusion related reaction	31.17	10.33	22	37844	101186	46547010
Asthenia	30.67	10.33	386	37480	310689	46337507
Synovitis	28.86	10.33	7	37859	61068	46587128
Lower respiratory tract infection	28.75	10.33	5	37861	55084	46593112
Exposure during pregnancy	27.83	10.33	28	37838	108184	46540012
Weight decreased	27.75	10.33	277	37589	210572	46437624
Pemphigus	26.22	10.33	3	37863	45271	46602925
Blood pressure decreased	25.63	10.33	103	37763	57056	46591140
Microvillous inclusion disease	25.45	10.33	5	37861	9	46648187
Off label use	25.00	10.33	193	37673	379648	46268548
Renal disorder	24.91	10.33	62	37804	26624	46621572
Systemic lupus erythematosus	24.62	10.33	11	37855	65169	46583027
Drug intolerance	24.16	10.33	52	37814	146997	46501199
Therapeutic product effect decreased	24.08	10.33	19	37847	82582	46565614
Blood creatinine increased	24.03	10.33	124	37742	76279	46571917
Collagen disorder	23.35	10.33	8	37858	192	46648004
Hypokalaemia	23.09	10.33	136	37730	87888	46560308
Oligohydramnios	22.69	10.33	25	37841	5440	46642756
Normocytic anaemia	22.30	10.33	13	37853	1126	46647070
Product administration error	21.93	10.33	49	37817	19632	46628564
Chronic kidney disease	21.92	10.33	78	37788	40793	46607403
Anti-transglutaminase antibody increased	21.70	10.33	4	37862	4	46648192
Normochromic anaemia	21.48	10.33	8	37858	246	46647950
Decreased appetite	21.46	10.33	246	37620	193590	46454606
Large intestine polyp	21.31	10.33	29	37837	7832	46640364
Lymphocytic infiltration	20.71	10.33	11	37855	795	46647401
Gastritis	20.53	10.33	68	37798	34310	46613886
Hepatic function abnormal	20.48	10.33	68	37798	34353	46613843
Enteritis	19.97	10.33	26	37840	6729	46641467
Diverticulum	19.95	10.33	34	37832	11172	46637024
Contraindicated product administered	19.09	10.33	22	37844	79925	46568271
Gastrointestinal ischaemia	18.80	10.33	7	37859	215	46647981
Hypoalbuminaemia	18.39	10.33	31	37835	10096	46638100
Hypotension	18.16	10.33	277	37589	232312	46415884
Angiosclerosis	18.05	10.33	4	37862	16	46648180
Product substitution issue	17.40	10.33	38	37828	14993	46633203
Liver disorder	17.40	10.33	68	37798	37178	46611018
Spleen congestion	17.17	10.33	6	37860	153	46648043
Product use issue	16.79	10.33	32	37834	94612	46553584
Infection	16.79	10.33	54	37812	133538	46514658
Burn oesophageal	16.71	10.33	6	37860	166	46648030
Oedema peripheral	15.61	10.33	198	37668	159508	46488688
Autoimmune enteropathy	15.42	10.33	3	37863	5	46648191
Hyperuricaemia	15.28	10.33	19	37847	4698	46643498
Gastrooesophageal reflux disease	15.27	10.33	108	37758	74236	46573960
Therapeutic product effect incomplete	15.15	10.33	25	37841	78128	46570068
Atrial tachycardia	15.02	10.33	13	37853	2107	46646089
Gastritis erosive	14.96	10.33	20	37846	5310	46642886
Haemorrhoids	14.84	10.33	41	37825	18736	46629460
Hypoglycaemic coma	14.73	10.33	14	37852	2560	46645636
Rhabdomyolysis	14.58	10.33	70	37796	41839	46606357
Hospitalisation	14.54	10.33	18	37848	63367	46584829
Aortic valve calcification	14.39	10.33	7	37859	420	46647776
Febrile neutropenia	14.29	10.33	35	37831	94592	46553604
Confabulation	14.08	10.33	6	37860	264	46647932
Pain	14.00	10.33	288	37578	476660	46171536
Leukocyturia	13.91	10.33	9	37857	939	46647257
Aortic dissection	13.86	10.33	11	37855	1581	46646615
Foetal exposure during pregnancy	13.62	10.33	4	37862	30743	46617453
Wound	13.58	10.33	9	37857	42793	46605403
Atrial fibrillation	13.55	10.33	136	37730	103454	46544742
Hiatus hernia	13.52	10.33	39	37827	18263	46629933
Hypocalcaemia	13.41	10.33	50	37816	26735	46621461
Putamen haemorrhage	13.33	10.33	5	37861	157	46648039
Device expulsion	13.32	10.33	3	37863	27539	46620657
Azotaemia	13.26	10.33	17	37849	4334	46643862
Heart rate irregular	13.15	10.33	39	37827	18552	46629644
Oesophagitis	13.04	10.33	32	37834	13619	46634577
Pregnancy	13.04	10.33	3	37863	27134	46621062
Varicose vein	12.99	10.33	17	37849	4421	46643775
Nail disorder	12.81	10.33	23	37843	7873	46640323
Bezoar	12.77	10.33	10	37856	1409	46646787
Prerenal failure	12.66	10.33	10	37856	1427	46646769
Pneumonia	12.64	10.33	222	37644	376098	46272098
Sopor	12.54	10.33	40	37826	19788	46628408
Polyp	12.49	10.33	18	37848	5125	46643071
Product use in unapproved indication	12.40	10.33	35	37831	90238	46557958
Neutropenia	12.32	10.33	67	37799	143137	46505059
Anuria	12.22	10.33	28	37838	11403	46636793
Joint swelling	12.04	10.33	82	37784	165991	46482205
Hepatorenal failure	11.87	10.33	7	37859	619	46647577
Lymphocyte stimulation test positive	11.83	10.33	7	37859	623	46647573
Purpura senile	11.78	10.33	7	37859	628	46647568
Pharyngeal haematoma	11.78	10.33	3	37863	24	46648172
Hair texture abnormal	11.74	10.33	13	37853	2843	46645353
Anti-insulin antibody positive	11.71	10.33	4	37862	95	46648101
Acquired oesophageal web	11.55	10.33	5	37861	229	46647967
Skin exfoliation	11.44	10.33	55	37811	32883	46615313
Hepatitis alcoholic	11.23	10.33	4	37862	108	46648088
Anaemia	11.19	10.33	279	37587	255500	46392696
Blood glucose increased	11.15	10.33	98	37768	71915	46576281
Brain stem haemorrhage	10.94	10.33	7	37859	716	46647480
Hypoperfusion	10.78	10.33	9	37857	1388	46646808
Hyperlactacidaemia	10.73	10.33	11	37855	2204	46645992
Musculoskeletal stiffness	10.71	10.33	42	37824	97951	46550245
Intentional overdose	10.63	10.33	23	37843	64921	46583275
Blood triglycerides increased	10.60	10.33	27	37839	11756	46636440
Mucosa vesicle	10.54	10.33	3	37863	38	46648158
Withdrawal hypertension	10.33	10.33	4	37862	137	46648059

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
Malabsorption	376.23	11.44	117	26371	1870	29924120
Sprue-like enteropathy	354.39	11.44	78	26410	269	29925721
Intestinal villi atrophy	86.79	11.44	21	26467	120	29925870
Gastrointestinal disorder	77.03	11.44	109	26379	28028	29897962
Blood pressure increased	68.00	11.44	177	26311	71751	29854239
Coeliac disease	64.05	11.44	23	26465	582	29925408
Cerebral infarction	61.84	11.44	95	26393	26278	29899712
Renal impairment	60.85	11.44	188	26300	83996	29841994
Death	58.58	11.44	145	26343	357138	29568852
Hepatic function abnormal	56.94	11.44	119	26369	41826	29884164
Toxicity to various agents	53.32	11.44	47	26441	177136	29748854
Hyperkalaemia	49.15	11.44	149	26339	65861	29860129
Interstitial lung disease	47.78	11.44	139	26349	60058	29865932
Blood pressure decreased	46.68	11.44	118	26370	46957	29879033
Hyperuricaemia	46.45	11.44	44	26444	7350	29918640
Hypertension	45.48	11.44	220	26268	121134	29804856
Colitis microscopic	38.51	11.44	22	26466	1681	29924309
Syncope	37.81	11.44	162	26326	84741	29841249
Diarrhoea	37.40	11.44	455	26033	333648	29592342
Loss of consciousness	33.46	11.44	149	26339	79226	29846764
Intestinal intraepithelial lymphocytes increased	32.56	11.44	6	26482	5	29925985
Completed suicide	31.60	11.44	25	26463	99467	29826523
Dermatitis infected	31.22	11.44	9	26479	109	29925881
Dehydration	30.34	11.44	200	26288	123339	29802651
Dizziness	28.93	11.44	281	26207	194628	29731362
Gastrointestinal erosion	28.23	11.44	11	26477	351	29925639
Microvillous inclusion disease	27.83	11.44	7	26481	48	29925942
Hypotension	27.28	11.44	284	26204	200281	29725709
Product use in unapproved indication	26.75	11.44	16	26472	73677	29852313
Lymphangiectasia intestinal	26.70	11.44	5	26483	5	29925985
Pancreatic neoplasm	26.11	11.44	14	26474	945	29925045
Hospitalisation	26.09	11.44	4	26484	44315	29881675
Acute kidney injury	25.97	11.44	362	26126	273480	29652510
Hyperkinetic heart syndrome	25.94	11.44	8	26480	124	29925866
Hypertensive crisis	25.29	11.44	34	26454	8323	29917667
Off label use	25.28	11.44	124	26364	249166	29676824
Weight decreased	23.56	11.44	220	26268	150701	29775289
Neutropenia	23.52	11.44	49	26439	128491	29797499
Liver disorder	22.95	11.44	68	26420	29654	29896336
Atrophy	22.39	11.44	13	26475	1024	29924966
Renal disorder	22.20	11.44	58	26430	23526	29902464
Palmar-plantar erythrodysaesthesia syndrome	19.94	11.44	42	26446	14828	29911162
Hypokalaemia	19.48	11.44	92	26396	50100	29875890
Transient aphasia	18.32	11.44	6	26482	114	29925876
Renal failure	18.15	11.44	184	26304	128782	29797208
Enterocolitis viral	18.12	11.44	5	26483	51	29925939
Tropical sprue	18.10	11.44	3	26485	0	29925990
Borderline personality disorder	17.60	11.44	8	26480	377	29925613
Plasma cell myeloma	17.52	11.44	13	26475	53449	29872541
Blood pressure inadequately controlled	17.50	11.44	16	26472	2554	29923436
Product administration error	17.44	11.44	39	26449	14338	29911652
Chronic kidney disease	17.44	11.44	73	26415	37765	29888225
Immune-mediated myositis	17.42	11.44	12	26476	1273	29924717
Gastrooesophageal reflux disease	17.09	11.44	65	26423	32190	29893800
Pulmonary hypoplasia	16.73	11.44	8	26480	423	29925567
Anaplastic astrocytoma	16.45	11.44	6	26482	159	29925831
Drug abuse	16.11	11.44	30	26458	82042	29843948
Autoimmune enteropathy	16.09	11.44	4	26484	26	29925964
Cerebral haemorrhage	15.59	11.44	64	26424	32823	29893167
Drug ineffective	15.56	11.44	210	26278	340177	29585813
Large intestine polyp	15.48	11.44	24	26464	6685	29919305
Prerenal failure	15.46	11.44	13	26475	1858	29924132
Sinus node dysfunction	15.41	11.44	18	26470	3825	29922165
Colon cancer	15.35	11.44	27	26461	8345	29917645
Anaemia	15.10	11.44	263	26225	207729	29718261
Gastroenteritis	15.00	11.44	35	26453	13231	29912759
Treatment failure	14.89	11.44	6	26482	34673	29891317
Haemorrhoids	14.80	11.44	33	26455	12108	29913882
Febrile neutropenia	14.64	11.44	47	26441	106646	29819344
Hypoalbuminaemia	14.49	11.44	31	26457	11061	29914929
Decreased appetite	14.49	11.44	199	26289	149711	29776279
Peripheral venous disease	14.44	11.44	13	26475	2035	29923955
Product odour abnormal	14.24	11.44	8	26480	592	29925398
Collagen disorder	14.21	11.44	5	26483	119	29925871
Hypertensive emergency	14.16	11.44	9	26479	835	29925155
Tinea pedis	13.91	11.44	10	26478	1136	29924854
Renal cyst haemorrhage	13.35	11.44	5	26483	143	29925847
Gastric cancer	13.27	11.44	19	26469	4931	29921059
Oligohydramnios	12.79	11.44	6	26482	304	29925686
Echocardiogram abnormal	12.76	11.44	8	26480	724	29925266
Helicobacter test positive	12.73	11.44	7	26481	497	29925493
Peripheral arterial occlusive disease	12.65	11.44	19	26469	5149	29920841
Intestinal ulcer perforation	12.57	11.44	3	26485	16	29925974
Blood creatinine increased	12.19	11.44	129	26359	91246	29834744
Gastrointestinal mucosa hyperaemia	12.16	11.44	5	26483	184	29925806
Pancytopenia	11.99	11.44	37	26451	85015	29840975
Blood creatine phosphokinase abnormal	11.94	11.44	5	26483	193	29925797
Rectal ulcer haemorrhage	11.84	11.44	4	26484	84	29925906
Diabetic nephropathy	11.50	11.44	11	26477	1858	29924132
Atrioventricular block	11.47	11.44	22	26466	7260	29918730

Pharmacologic Action:

Source	Code	Description
ATC	C09CA08	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN Angiotensin II receptor blockers (ARBs), plain
ATC	C09DA08	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and diuretics
ATC	C09DB02	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC	C09DX03	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
MeSH PA	D047228	Angiotensin II Type 1 Receptor Blockers
MeSH PA	D057911	Angiotensin Receptor Antagonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
FDA MoA	N0000000070	Angiotensin 2 Receptor Antagonists
FDA EPC	N0000175561	Angiotensin 2 Receptor Blocker
CHEBI has role	CHEBI:35674	antihypertensive
CHEBI has role	CHEBI:61016	angiotensin receptor antagonists

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Chronic heart failure	off-label use	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diastolic heart failure	off-label use	418304008	DOID:9775
Nondiabetic Proteinuric Nephropathy	off-label use
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Secondary angle-closure glaucoma	contraindication	21571006
Hypovolemia	contraindication	28560003
Dehydration	contraindication	34095006
Hyperuricemia	contraindication	35885006	DOID:1920
Angioedema	contraindication	41291007	DOID:1558
Hypokalemia	contraindication	43339004
Diabetes mellitus type 2	contraindication	44054006	DOID:9352
Low blood pressure	contraindication	45007003
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Sympathectomy	contraindication	57071006
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
Kidney disease	contraindication	90708001	DOID:557
Hypomagnesemia	contraindication	190855004
Acute pancreatitis	contraindication	197456007	DOID:2913
Neonatal hyperbilirubinemia	contraindication	281610001
Pregnancy, function	contraindication	289908002
Renal artery stenosis	contraindication	302233006
Azotemia	contraindication	445009001
Severe Aortic Valve Stenosis	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.25	acidic
pKa2	5.76	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])	Mechanism action	Bioact source	MoA source
Type-1 angiotensin II receptor	GPCR	P30556	AGTR1_HUMAN	ANTAGONIST	IC50	8.10		IUPHAR	CHEMBL
Type-1 angiotensin II receptor	GPCR		AGTR1_BOVIN		IC50	8.09		CHEMBL

External reference:

ID	Source
4021345	VUID
N0000179505	NUI
D01204	KEGG_DRUG
144689-24-7	SECONDARY_CAS_RN
4021344	VANDF
4021345	VANDF
C0386394	UMLSCUI
C1098320	UMLSCUI
CHEBI:31932	CHEBI
CHEBI:48416	CHEBI
OLM	PDB_CHEM_ID
CHEMBL1200692	ChEMBL_ID
CHEMBL1516	ChEMBL_ID
D000068557	MESH_DESCRIPTOR_UI
130881	PUBCHEM_CID
C437965	MESH_SUPPLEMENTAL_RECORD_UI
7787	INN_ID
8612	INN_ID
6M97XTV3HD	UNII
8W1IQP3U10	UNII
158781	PUBCHEM_CID
591	IUPHAR_LIGAND_ID
DB00275	DRUGBANK_ID
118463	RXNORM
16642	MMSL
245076	MMSL
d04801	MMSL
009634	NDDF
009635	NDDF
385540001	SNOMEDCT_US
412259001	SNOMEDCT_US
412260006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5002	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5003	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5004	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5005	TABLET, FILM COATED	20 mg	ORAL	ANDA	26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5006	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	13668-248	TABLET	5 mg	ORAL	ANDA	21 sections
Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	13668-249	TABLET	20 mg	ORAL	ANDA	21 sections
Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	13668-250	TABLET	40 mg	ORAL	ANDA	21 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	13668-251	TABLET	20 mg	ORAL	ANDA	20 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	13668-252	TABLET	40 mg	ORAL	ANDA	20 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	13668-253	TABLET	40 mg	ORAL	ANDA	20 sections
Amlodipine and Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	2	13668-311	TABLET	40 mg	ORAL	ANDA	21 sections
Amlodipine and Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	2	13668-312	TABLET	20 mg	ORAL	ANDA	21 sections
Amlodipine and Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	2	13668-313	TABLET	40 mg	ORAL	ANDA	21 sections
Amlodipine and Olmesartan Medoxomil	HUMAN PRESCRIPTION DRUG LABEL	2	13668-324	TABLET	20 mg	ORAL	ANDA	21 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg	HUMAN PRESCRIPTION DRUG LABEL	3	13668-382	TABLET	40 mg	ORAL	ANDA	25 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg	HUMAN PRESCRIPTION DRUG LABEL	3	13668-383	TABLET	40 mg	ORAL	ANDA	25 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg	HUMAN PRESCRIPTION DRUG LABEL	3	13668-385	TABLET	40 mg	ORAL	ANDA	25 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg	HUMAN PRESCRIPTION DRUG LABEL	3	13668-386	TABLET	40 mg	ORAL	ANDA	25 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg	HUMAN PRESCRIPTION DRUG LABEL	3	13668-397	TABLET	20 mg	ORAL	ANDA	25 sections
olmesartan medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-320	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
olmesartan medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-321	TABLET, FILM COATED	20 mg	ORAL	ANDA	27 sections
olmesartan medoxomil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-322	TABLET, FILM COATED	40 mg	ORAL	ANDA	27 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	16729-366	TABLET, FILM COATED	20 mg	ORAL	ANDA	26 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	16729-367	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HUMAN PRESCRIPTION DRUG LABEL	2	16729-368	TABLET, FILM COATED	40 mg	ORAL	ANDA	26 sections
Amlodipine besylate and Olmesartan medoxomil	Human Prescription Drug Label	2	27241-083	TABLET	20 mg	ORAL	ANDA	26 sections
Amlodipine besylate and Olmesartan medoxomil	Human Prescription Drug Label	2	27241-084	TABLET	40 mg	ORAL	ANDA	26 sections
Amlodipine besylate and Olmesartan medoxomil	Human Prescription Drug Label	2	27241-085	TABLET	20 mg	ORAL	ANDA	26 sections
Amlodipine besylate and Olmesartan medoxomil	Human Prescription Drug Label	2	27241-086	TABLET	40 mg	ORAL	ANDA	26 sections