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

Stem definition	Drug id	CAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors	1229	93957-54-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lescol fluvastatin leschol fluvastatin sodium XU-62-320 fluvastatin sodium salt fluvastatin sodium hydrate	An indole-heptanoic acid derivative that inhibits HMG COA REDUCTASE and is used to treat HYPERCHOLESTEROLEMIA. In contrast to other statins, it does not appear to interact with other drugs that inhibit CYP3A4. Molecular weight: 411.47 Formula: C24H26FNO4 CLOGP: 4.05 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 82.69 ALOGS: -4.97 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lescol
fluvastatin
leschol
fluvastatin sodium
XU-62-320
fluvastatin sodium salt
fluvastatin sodium hydrate

An indole-heptanoic acid derivative that inhibits HMG COA REDUCTASE and is used to treat HYPERCHOLESTEROLEMIA. In contrast to other statins, it does not appear to interact with other drugs that inhibit CYP3A4.

Molecular weight: 411.47
Formula: C24H26FNO4
CLOGP: 4.05
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 82.69
ALOGS: -4.97
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.62 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	24 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.42 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	16 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.70 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 31, 1993	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
Myalgia	138.13	14.61	136	8540	124183	50472265
Blood creatine phosphokinase increased	115.69	14.61	66	8610	26301	50570147
Rhabdomyolysis	115.65	14.61	76	8600	38951	50557497
Limb reduction defect	100.00	14.61	21	8655	366	50596082
Dysmorphism	72.29	14.61	23	8653	2144	50594304
Cleft palate	71.35	14.61	19	8657	944	50595504
Gamma-glutamyltransferase increased	65	14.61	48	8628	29575	50566873
Talipes	64.13	14.61	19	8657	1395	50595053
Atrial septal defect	64.09	14.61	28	8648	6313	50590135
Patent ductus arteriosus	59.54	14.61	23	8653	3797	50592651
Limb hypoplasia congenital	58.58	14.61	12	8664	184	50596264
Antinuclear antibody negative	57.42	14.61	12	8664	204	50596244
Congenital oral malformation	52.80	14.61	11	8665	184	50596264
Coombs positive haemolytic anaemia	52.03	14.61	12	8664	327	50596121
Herpes simplex reactivation	50.14	14.61	12	8664	385	50596063
Retrognathia	49.36	14.61	12	8664	412	50596036
Aspartate aminotransferase increased	48.16	14.61	63	8613	77935	50518513
Drug ineffective	47.12	14.61	43	8633	819290	49777158
Alanine aminotransferase increased	46.43	14.61	66	8610	88293	50508155
Developmental hip dysplasia	44.29	14.61	14	8662	1277	50595171
Myopathy	40.38	14.61	23	8653	9116	50587332
Antiphospholipid syndrome	38.12	14.61	13	8663	1504	50594944
Gastritis haemorrhagic	35.73	14.61	12	8664	1325	50595123
Neck deformity	34.75	14.61	13	8663	1965	50594483
Lactic acidosis	32.38	14.61	34	8642	33321	50563127
Acute kidney injury	32.28	14.61	99	8577	227959	50368489
Jaundice	31.28	14.61	30	8646	26399	50570049
Complex regional pain syndrome	31.06	14.61	12	8664	1981	50594467
Anxiety disorder	30.06	14.61	14	8662	3659	50592789
Pancreatitis acute	30.03	14.61	28	8648	23784	50572664
Premature baby	27.95	14.61	24	8652	18313	50578135
Interstitial lung disease	26.85	14.61	39	8637	53137	50543311
Aplasia	26.53	14.61	13	8663	3800	50592648
Muscle spasms	26.28	14.61	63	8613	125490	50470958
Muscular weakness	25.90	14.61	53	8623	94960	50501488
Blood alkaline phosphatase increased	25.81	14.61	32	8644	37494	50558954
Off label use	23.64	14.61	28	8648	474398	50122050
Hyperlipidaemia	22.89	14.61	21	8655	17469	50578979
Peripheral swelling	22.65	14.61	4	8672	205932	50390516
Neonatal seizure	21.17	14.61	6	8670	376	50596072
Pulmonary artery stenosis	20.84	14.61	5	8671	162	50596286
Alopecia	20.81	14.61	8	8668	245039	50351409
Hypernatraemia	20.39	14.61	13	8663	6308	50590140
Blood creatinine increased	20.18	14.61	42	8634	76118	50520330
Chromaturia	20.04	14.61	18	8658	14572	50581876
Coronary artery disease	19.88	14.61	25	8651	29701	50566747
Erysipelas	19.86	14.61	13	8663	6595	50589853
Joint swelling	19.24	14.61	9	8667	245277	50351171
Otospondylomegaepiphyseal dysplasia	18.92	14.61	4	8672	72	50596376
Angiosclerosis	18.86	14.61	3	8673	9	50596439
Cerebrovascular accident	18.20	14.61	46	8630	94634	50501814
Drug interaction	18.16	14.61	75	8601	199546	50396902
Haematoma	17.82	14.61	24	8652	30486	50565962
Pleuritic pain	17.70	14.61	12	8664	6454	50589994
Blood urea increased	17.66	14.61	21	8655	23564	50572884
Osteonecrosis	16.78	14.61	20	8656	22497	50573951
Bradycardia neonatal	16.48	14.61	6	8670	840	50595608
Sterile pyuria	16.43	14.61	3	8673	24	50596424
Cholestasis	16.41	14.61	21	8655	25380	50571068
Ocular myasthenia	16.40	14.61	4	8672	139	50596309
Cerebral ischaemia	16.26	14.61	11	8665	5897	50590551
Hypothyroidism	15.75	14.61	24	8652	34101	50562347
Fasciitis	15.39	14.61	5	8671	498	50595950
Amyotrophic lateral sclerosis	15.13	14.61	6	8670	1061	50595387

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
Myalgia	262.85	16.11	195	8173	73824	29492335
Blood creatine phosphokinase increased	161.94	16.11	115	8253	40529	29525630
Myopathy	77.54	16.11	44	8324	10489	29555670
Muscle rupture	74.16	16.11	26	8342	1971	29564188
Gamma-glutamyltransferase increased	48.35	16.11	48	8320	26689	29539470
Rectal prolapse	43.71	16.11	11	8357	260	29565899
Off label use	42.66	16.11	16	8352	300784	29265375
Amyotrophic lateral sclerosis	42.50	16.11	14	8354	877	29565282
Rhabdomyolysis	41.44	16.11	67	8301	60741	29505418
Intraductal papillary mucinous neoplasm	41.24	16.11	11	8357	329	29565830
Vena cava injury	40.95	16.11	10	8358	208	29565951
SARS-CoV-2 antibody test positive	40.29	16.11	10	8358	223	29565936
Renal cyst haemorrhage	39.33	16.11	11	8357	394	29565765
Dysuria	32.87	16.11	36	8332	22404	29543755
Vestibular neuronitis	32.78	16.11	8	8360	166	29565993
Myocardial infarction	31.55	16.11	85	8283	110211	29455948
Face oedema	29.58	16.11	24	8344	10259	29555900
Aspartate aminotransferase increased	29.30	16.11	57	8311	59668	29506491
Angina pectoris	28.15	16.11	37	8331	27813	29538346
General physical health deterioration	28.14	16.11	78	8290	102779	29463380
Tendon rupture	27.78	16.11	19	8349	6276	29559883
Diverticulum intestinal	27.64	16.11	15	8353	3275	29562884
Generalised oedema	25.84	16.11	23	8345	11142	29555017
Carotid arteriosclerosis	25.68	16.11	11	8357	1427	29564732
Delayed graft function	25.65	16.11	12	8356	1915	29564244
Coronary artery disease	25.20	16.11	45	8323	44145	29522014
Febrile bone marrow aplasia	25.13	16.11	19	8349	7332	29558827
Abdominal wall haemorrhage	25.07	16.11	7	8361	249	29565910
Toxicity to various agents	24.96	16.11	9	8359	173652	29392507
Restless legs syndrome	23.76	16.11	18	8350	6966	29559193
Vertigo	23.59	16.11	30	8338	21831	29544328
Death	23.47	16.11	38	8330	342046	29224113
Aortic dilatation	22.43	16.11	9	8359	990	29565169
Renal artery stenosis	22.42	16.11	11	8357	1950	29564209
Glycosylated haemoglobin increased	20.99	16.11	19	8349	9407	29556752
Mean cell volume increased	19.94	16.11	11	8357	2478	29563681
Perioral dermatitis	19.91	16.11	5	8363	117	29566042
Myocardial ischaemia	18.90	16.11	23	8345	16005	29550154
Congenital inguinal hernia	18.48	16.11	5	8363	158	29566001
Vitamin D decreased	18.29	16.11	11	8357	2914	29563245
Actinic keratosis	18.07	16.11	12	8356	3774	29562385
Funguria	17.87	16.11	4	8364	56	29566103
Aortic arteriosclerosis	17.82	16.11	12	8356	3864	29562295
Product dose omission issue	17.69	16.11	3	8365	96380	29469779
Haemorrhoids	17.58	16.11	19	8349	11638	29554521
Hyperparathyroidism secondary	17.16	16.11	8	8360	1267	29564892
Seizure	16.86	16.11	3	8365	93120	29473039
Spinal stenosis	16.53	16.11	12	8356	4351	29561808
Vascular anastomotic haemorrhage	16.34	16.11	4	8364	84	29566075
Perineal cyst	16.12	16.11	4	8364	89	29566070

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
Myalgia	307.06	13.33	258	13185	158359	64326930
Blood creatine phosphokinase increased	244.29	13.33	152	13291	58406	64426883
Rhabdomyolysis	112.61	13.33	116	13327	91610	64393679
Myopathy	108.42	13.33	59	13384	17621	64467668
Gamma-glutamyltransferase increased	83.56	13.33	74	13369	48436	64436853
Aspartate aminotransferase increased	65.34	13.33	101	13342	119687	64365602
Off label use	64.09	13.33	26	13417	632780	63852509
Amyotrophic lateral sclerosis	57.58	13.33	19	13424	1631	64483658
Muscle rupture	55.60	13.33	22	13421	3178	64482111
Alanine aminotransferase increased	50.56	13.33	98	13345	138933	64346356
Vena cava injury	43.46	13.33	10	13433	220	64485069
SARS-CoV-2 antibody test positive	42.67	13.33	10	13433	239	64485050
Renal cyst haemorrhage	41.22	13.33	11	13432	451	64484838
Myocardial infarction	40.97	13.33	100	13343	165721	64319568
Coronary artery disease	38.73	13.33	55	13388	60378	64424911
Intraductal papillary mucinous neoplasm	38.43	13.33	11	13432	586	64484703
Toxicity to various agents	32.02	13.33	18	13425	363495	64121794
Completed suicide	30.66	13.33	5	13438	224409	64260880
Muscular weakness	30.59	13.33	76	13367	127262	64358027
Muscle spasms	29.59	13.33	80	13363	140943	64344346
Death	28.81	13.33	35	13408	482670	64002619
Lactic acidosis	28.29	13.33	48	13395	61362	64423927
Myoglobin blood increased	28.17	13.33	13	13430	2734	64482555
Blood alkaline phosphatase increased	27.28	13.33	45	13398	56234	64429055
Rectal prolapse	26.99	13.33	11	13432	1715	64483574
Joint swelling	26.87	13.33	6	13437	215376	64269913
Drug ineffective	26.85	13.33	88	13355	840159	63645130
Peripheral swelling	25.75	13.33	6	13437	209147	64276142
General physical health deterioration	25.52	13.33	97	13346	204328	64280961
Jaundice	25.15	13.33	40	13403	48472	64436817
Carotid arteriosclerosis	25.01	13.33	11	13432	2068	64483221
Cerebrovascular accident	24.91	13.33	74	13369	137509	64347780
Vestibular neuronitis	24.69	13.33	8	13435	648	64484641
Acute kidney injury	24.64	13.33	169	13274	449071	64036218
Blood creatinine increased	24.55	13.33	73	13370	135709	64349580
Delayed graft function	23.95	13.33	12	13431	3024	64482265
Tendon rupture	23.84	13.33	19	13424	10748	64474541
Abdominal wall haemorrhage	23.68	13.33	7	13436	418	64484871
Actinic keratosis	23.00	13.33	14	13429	5151	64480138
Hyperkalaemia	22.86	13.33	59	13384	101070	64384219
Face oedema	22.86	13.33	27	13416	24734	64460555
Myocardial ischaemia	22.54	13.33	26	13417	23225	64462064
Infusion related reaction	21.72	13.33	4	13439	164463	64320826
Renal artery stenosis	21.28	13.33	11	13432	2958	64482331
Blood urea increased	20.98	13.33	35	13408	44118	64441171
Dysuria	20.88	13.33	34	13409	42023	64443266
Benign prostatic hyperplasia	19.92	13.33	16	13427	9149	64476140
Muscle necrosis	19.83	13.33	8	13435	1215	64484074
Chromaturia	19.79	13.33	24	13419	22587	64462702
Product dose omission issue	19.64	13.33	8	13435	194739	64290550
General physical condition	19.13	13.33	3	13440	6	64485283
Aortic dilatation	18.77	13.33	8	13435	1395	64483894
Diverticulum intestinal	18.40	13.33	14	13429	7406	64477883
Aortic arteriosclerosis	18.30	13.33	14	13429	7462	64477827
Angiosclerosis	18.03	13.33	3	13440	10	64485279
Vascular anastomotic haemorrhage	17.56	13.33	4	13439	84	64485205
Perineal cyst	17.47	13.33	4	13439	86	64485203
Perioral dermatitis	17.44	13.33	5	13438	268	64485021
Drug interaction	17.39	13.33	132	13311	361951	64123338
Hepatic function abnormal	17.16	13.33	40	13403	64273	64421016
Blood lactate dehydrogenase increased	16.77	13.33	27	13416	33051	64452238
Acute myocardial infarction	16.09	13.33	41	13402	69677	64415612
Blood creatine phosphokinase MB	15.96	13.33	3	13440	23	64485266
Mean cell volume increased	15.88	13.33	11	13432	5035	64480254
Blood potassium increased	15.69	13.33	23	13420	25957	64459332
Hepatosplenomegaly	15.31	13.33	11	13432	5332	64479957
Interstitial lung disease	15.30	13.33	50	13393	97682	64387607
Pancreatitis acute	15.30	13.33	30	13413	42825	64442464
Palmoplantar keratoderma	15.24	13.33	5	13438	421	64484868
Febrile bone marrow aplasia	15.18	13.33	15	13428	11240	64474049
Product use in unapproved indication	15.16	13.33	9	13434	176609	64308680
Vertigo	14.98	13.33	36	13407	58975	64426314
Hyperparathyroidism secondary	14.90	13.33	8	13435	2322	64482967
Haematoma	14.87	13.33	31	13412	46219	64439070
Rheumatoid arthritis	14.64	13.33	8	13435	164286	64321003
Angina pectoris	14.24	13.33	30	13413	45051	64440238
Product use issue	14.09	13.33	7	13436	151708	64333581
Invasive lobular breast carcinoma	14.04	13.33	5	13438	540	64484749
Glycosylated haemoglobin increased	14.02	13.33	17	13426	16002	64469287
Cholestatic liver injury	13.93	13.33	9	13434	3670	64481619
Ureteric injury	13.88	13.33	3	13440	49	64485240
Activated partial thromboplastin time prolonged	13.55	13.33	15	13428	12816	64472473
Alopecia	13.46	13.33	9	13434	165681	64319608
Blood bilirubin increased	13.44	13.33	34	13409	57519	64427770
Nephrotic syndrome	13.37	13.33	13	13430	9554	64475735

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C10AA04	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN HMG CoA reductase inhibitors
FDA MoA	N0000000121	Hydroxymethylglutaryl-CoA Reductase Inhibitors
FDA EPC	N0000175589	HMG-CoA Reductase Inhibitor
CHEBI has role	CHEBI:35679	antilipemic drugs
CHEBI has role	CHEBI:77255	lethal toxin inhibitors
CHEBI has role	CHEBI:35821	anticholesteremic drugs

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

Disease	Relation	SNOMED_ID	DOID
Hypercholesterolemia	indication	13644009
Arteriosclerotic vascular disease	indication	72092001
Familial hypercholesterolemia - heterozygous	indication	238079002
Mixed hyperlipidemia	indication	267434003
Slow Progression of Coronary Artery Disease	indication
Cerebrovascular accident	off-label use	230690007
Myocardial Infarction Prevention	off-label use
Primary Prevention of Coronary Heart Disease	off-label use
Prevention of Transient Ischemic Attacks	off-label use
Alcoholism	contraindication	7200002
Low blood pressure	contraindication	45007003
Acute nephropathy	contraindication	58574008
Disorder of muscle	contraindication	129565002	DOID:423
Liver function tests abnormal	contraindication	166603001
Hemorrhagic cerebral infarction	contraindication	230706003
Disease of liver	contraindication	235856003	DOID:409
Rhabdomyolysis	contraindication	240131006
Pregnancy, function	contraindication	289908002
Surgical procedure	contraindication	387713003
Breastfeeding (mother)	contraindication	413712001
Traumatic injury	contraindication	417746004
Uncontrolled Epilepsy	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	4.05	acidic
pKa2	13.34	acidic
pKa3	13.99	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])	Bioact source	MoA source
3-hydroxy-3-methylglutaryl-coenzyme A reductase	Enzyme	P04035	HMDH_HUMAN	INHIBITOR	IC50	7.55	CHEMBL	DRUG LABEL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	6.40	DRUG MATRIX
Retinoic acid receptor RXR-alpha	Nuclear hormone receptor	P19793	RXRA_HUMAN		Kd	4.96	CHEMBL
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN				WOMBAT-PK
Sodium/bile acid cotransporter	Transporter	Q14973	NTCP_HUMAN		IC50	4.40	CHEMBL
NAD-dependent protein deacetylase sirtuin-6	Unclassified	Q8N6T7	SIR6_HUMAN		EC50	5.15	CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase	Enzyme		HMDH_RAT		IC50	8.60	CHEMBL

External reference:

ID	Source
D00892	KEGG_DRUG
93957-55-2	SECONDARY_CAS_RN
4020854	VANDF
4023909	VANDF
C0082608	UMLSCUI
CHEBI:38561	CHEBI
115	PDB_CHEM_ID
CHEMBL2220442	ChEMBL_ID
CHEMBL1078	ChEMBL_ID
CHEMBL2218894	ChEMBL_ID
D000077340	MESH_DESCRIPTOR_UI
DB01095	DRUGBANK_ID
23663976	PUBCHEM_CID
2951	IUPHAR_LIGAND_ID
6547	INN_ID
4L066368AS	UNII
151972	RXNORM
1724	MMSL
189348	MMSL
4757	MMSL
d03183	MMSL
004439	NDDF
004440	NDDF
387585004	SNOMEDCT_US
412392009	SNOMEDCT_US
96307003	SNOMEDCT_US
CHEMBL103585	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LescolXL	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0354	TABLET, EXTENDED RELEASE	80 mg	ORAL	NDA	30 sections
LescolXL	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0354	TABLET, EXTENDED RELEASE	80 mg	ORAL	NDA	30 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7442	CAPSULE	20 mg	ORAL	ANDA	26 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7443	CAPSULE	40 mg	ORAL	ANDA	26 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7446	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	ANDA	28 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8020	CAPSULE	20 mg	ORAL	ANDA	26 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8021	CAPSULE	40 mg	ORAL	ANDA	26 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0527-2580	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	ANDA	30 sections
FLUVASTATIN SODIUMER	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8017	TABLET, EXTENDED RELEASE	80 mg	ORAL	NDA authorized generic	27 sections
LESCOL	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3329	CAPSULE	20 mg	ORAL	NDA	15 sections
LESCOL	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4224	CAPSULE	40 mg	ORAL	NDA	15 sections
LESCOL XL	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4601	TABLET, EXTENDED RELEASE	80 mg	ORAL	NDA	15 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8737	CAPSULE	40 mg	ORAL	ANDA	26 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8737	CAPSULE	40 mg	ORAL	ANDA	26 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8812	CAPSULE	20 mg	ORAL	ANDA	26 sections
Fluvastatin	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8812	CAPSULE	20 mg	ORAL	ANDA	26 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	68151-1326	CAPSULE	20 mg	ORAL	ANDA	25 sections
Fluvastatin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	68151-1334	CAPSULE	40 mg	ORAL	ANDA	25 sections
Lescol XL	HUMAN PRESCRIPTION DRUG LABEL	1	68151-4471	TABLET, EXTENDED RELEASE	80 mg	ORAL	NDA	26 sections