pitavastatin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors 2214 147511-69-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nisvastatin
  • itavastatin
  • pitavastatin calcium hydrate
  • pitavastatin
  • pitavastatin calcium
  • livalo
Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins.
  • Molecular weight: 421.47
  • Formula: C25H24FNO4
  • CLOGP: 3.59
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 90.65
  • ALOGS: -5.03
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
2 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 0.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.85 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) 4.60 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 51 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 0.80 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,EIF2AK3,GRK2,ITK,PDK1,PDK2,PDK4,PRKDC,TGFBR1 9
kinase-selectivity-class ACVR2B,AXL 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 14.622 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
rat-kpuu-brain Rat brain Kpuu 0.011 % High 1

Approvals:

DateAgencyCompanyOrphan
Aug. 3, 2009 FDA KOWA CO
June 26, 2015 PMDA Kowa Company, Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Myalgia 247.54 16.75 168 7947 174957 90445375
Hepatic function abnormal 121.06 16.75 66 8049 46222 90574110
Cerebral infarction 110.88 16.75 52 8063 26544 90593788
Rhabdomyolysis 74.13 16.75 50 8065 51206 90569126
Blood creatine phosphokinase increased 68.72 16.75 41 8074 33982 90586350
Renal impairment 58.72 16.75 59 8056 105362 90514970
Haemorrhage subcutaneous 47.73 16.75 16 8099 3380 90616952
Interstitial lung disease 46.70 16.75 45 8070 76360 90543972
Anaemia 39.24 16.75 93 8022 352709 90267623
Altered state of consciousness 39.10 16.75 28 8087 31504 90588828
Platelet count decreased 38.42 16.75 54 8061 136915 90483417
Drug eruption 34.04 16.75 27 8088 35380 90584952
Enterocolitis 33.19 16.75 17 8098 10473 90609859
Pemphigoid 32.59 16.75 16 8099 9010 90611322
Lymphocyte stimulation test positive 28.54 16.75 7 8108 484 90619848
Hypoglycaemia 28.19 16.75 33 8082 69815 90550517
Aspartate aminotransferase increased 27.99 16.75 40 8075 102897 90517435
Alanine aminotransferase increased 27.89 16.75 43 8072 118295 90502037
Akinesia 27.69 16.75 9 8106 1727 90618605
Vulvovaginal inflammation 27.29 16.75 8 8107 1090 90619242
Liver disorder 27.10 16.75 43 8072 121226 90499106
Muscle spasms 26.47 16.75 65 8050 251818 90368514
Cardiac failure 26.10 16.75 40 8075 109456 90510876
Toxic encephalopathy 24.38 16.75 13 8102 8686 90611646
Decreased appetite 23.85 16.75 81 8034 376459 90243873
Erythema multiforme 22.76 16.75 14 8101 12232 90608100
Glucose-6-phosphate dehydrogenase deficiency 22.36 16.75 5 8110 231 90620101
Systemic lupus erythematosus 22.32 16.75 3 8112 361893 90258439
Gingival oedema 20.54 16.75 4 8111 93 90620239
Cerebral haemorrhage 20.45 16.75 20 8095 34502 90585830
Upper respiratory tract inflammation 20.32 16.75 8 8107 2664 90617668
Hyperkalaemia 20.29 16.75 27 8088 64937 90555395
Pneumonia bacterial 19.74 16.75 13 8102 12777 90607555
Pancreatic carcinoma 19.30 16.75 11 8104 8366 90611966
Myopathy 19.08 16.75 13 8102 13505 90606827
Myocardial infarction 18.92 16.75 34 8081 105938 90514394
Dyspnoea at rest 18.83 16.75 9 8106 4782 90615550
Gastric dysplasia 18.49 16.75 3 8112 23 90620309
Vessel puncture site haematoma 18.45 16.75 4 8111 160 90620172
Arthropathy 18.44 16.75 5 8110 366237 90254095
Cardiac failure acute 18.10 16.75 12 8103 11917 90608415
Chronic kidney disease 17.46 16.75 22 8093 50169 90570163
Embolic stroke 17.08 16.75 8 8107 4064 90616268
Blood urea increased 16.87 16.75 17 8098 30396 90589936

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Interstitial lung disease 136.03 15.74 118 8435 78344 42534438
Hepatic function abnormal 133.12 15.74 98 8455 51469 42561313
Myalgia 130.48 15.74 126 8427 95954 42516828
Cerebral infarction 110.43 15.74 72 8481 31097 42581685
Blood creatine phosphokinase increased 90.41 15.74 76 8477 48262 42564520
Rhabdomyolysis 49.17 15.74 69 8484 77950 42534832
Cardiac failure 45.66 15.74 79 8474 106777 42506005
Angina pectoris 42.39 15.74 42 8511 32854 42579928
Immune-mediated myositis 39.72 15.74 18 8535 3775 42609007
Liver disorder 35.90 15.74 42 8511 39602 42573180
Aspartate aminotransferase increased 32.87 15.74 57 8496 77106 42535676
Pemphigoid 32.27 15.74 23 8530 11444 42601338
Renal impairment 30.61 15.74 68 8485 110160 42502622
Hyperuricaemia 29.08 15.74 20 8533 9404 42603378
Subdural haematoma 28.80 15.74 29 8524 23109 42589673
Visceral pain 28.53 15.74 6 8547 89 42612693
Death 27.04 15.74 33 8520 471152 42141630
Decreased appetite 23.89 15.74 89 8464 193048 42419734
Glycosylated haemoglobin increased 23.47 15.74 20 8533 12904 42599878
Drug-induced liver injury 22.83 15.74 33 8520 38240 42574542
Urine ketone body present 22.52 15.74 9 8544 1385 42611397
Prostate cancer 21.69 15.74 35 8518 44608 42568174
Pneumonia aspiration 21.32 15.74 37 8516 50041 42562741
Alanine aminotransferase increased 20.66 15.74 51 8502 88355 42524427
Pulmonary sepsis 20.50 15.74 11 8542 3313 42609469
Drug eruption 20.14 15.74 24 8529 23051 42589731
Gastric cancer 19.78 15.74 14 8539 6889 42605893
Colon cancer 19.69 15.74 16 8537 9665 42603117
Embolic cerebral infarction 18.87 15.74 7 8546 882 42611900
Cardiac failure acute 18.66 15.74 18 8535 13615 42599167
Bronchitis chronic 18.34 15.74 8 8545 1533 42611249
Anaemia 17.57 15.74 106 8447 280172 42332610
Gamma-glutamyltransferase 17.52 15.74 3 8550 13 42612769
Myopathy 16.67 15.74 17 8536 13744 42599038
Diabetes mellitus 16.58 15.74 37 8516 60050 42552732
Pyelonephritis 15.93 15.74 13 8540 7901 42604881
Diverticulum intestinal haemorrhagic 15.90 15.74 9 8544 3010 42609772

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Myalgia 315.08 14.24 263 16321 222118 110350597
Hepatic function abnormal 248.45 14.24 159 16425 89136 110483579
Cerebral infarction 208.37 14.24 117 16467 51721 110520994
Interstitial lung disease 177.05 14.24 155 16429 139179 110433536
Blood creatine phosphokinase increased 141.25 14.24 104 16480 72973 110499742
Rhabdomyolysis 110.73 14.24 112 16472 120289 110452426
Renal impairment 80.60 14.24 119 16465 188326 110384389
Altered state of consciousness 68.90 14.24 62 16522 57564 110515151
Pemphigoid 64.61 14.24 39 16545 19668 110553047
Cardiac failure 62.92 14.24 106 16478 187520 110385195
Aspartate aminotransferase increased 55.81 14.24 92 16492 159844 110412871
Decreased appetite 55.49 14.24 177 16407 475669 110097046
Immune-mediated myositis 51.79 14.24 23 16561 6163 110566552
Anaemia 51.11 14.24 189 16395 546897 110025818
Amaurosis fugax 48.98 14.24 17 16567 2373 110570342
Angina pectoris 48.40 14.24 53 16531 62242 110510473
Drug eruption 45.82 14.24 48 16536 53611 110519104
Platelet count decreased 45.29 14.24 104 16480 230339 110342376
Alanine aminotransferase increased 44.19 14.24 90 16494 183683 110389032
Liver disorder 43.27 14.24 77 16507 142166 110430549
Hyperuricaemia 40.66 14.24 26 16558 14505 110558210
Drug ineffective 38.26 14.24 110 16474 1520430 109052285
Haemorrhage subcutaneous 38.21 14.24 18 16566 5521 110567194
Enterocolitis 34.42 14.24 26 16558 18923 110553792
Myopathy 34.14 14.24 29 16555 24931 110547784
Subdural haematoma 33.63 14.24 34 16550 36420 110536295
Glycosylated haemoglobin increased 33.45 14.24 28 16556 23591 110549124
Cardiac failure acute 32.98 14.24 28 16556 24050 110548665
Confusional state 32.21 14.24 15 16569 468665 110104050
Hypoglycaemia 31.70 14.24 60 16524 116044 110456671
Pneumonia bacterial 30.88 14.24 28 16556 26233 110546482
Ocular discomfort 30.88 14.24 18 16566 8515 110564200
Colon cancer 30.84 14.24 23 16561 16420 110556295
Pneumonia aspiration 30.04 14.24 48 16536 81185 110491530
Upper respiratory tract inflammation 29.52 14.24 14 16570 4357 110568358
Prostate cancer 29.19 14.24 32 16552 37609 110535106
Urinary tract disorder 28.48 14.24 15 16569 5829 110566886
Treatment failure 28.25 14.24 4 16580 277230 110295485
Visceral pain 27.79 14.24 6 16578 138 110572577
Lymphocyte stimulation test positive 27.52 14.24 9 16575 1047 110571668
Arthropathy 27.39 14.24 5 16579 287517 110285198
Diabetes mellitus 26.69 14.24 51 16533 99330 110473385
Gastric cancer 26.66 14.24 18 16566 10990 110561725
Haematuria 26.61 14.24 46 16538 82959 110489756
Akinesia 25.55 14.24 12 16572 3655 110569060
Embolic stroke 25.35 14.24 16 16568 8727 110563988
Haemorrhagic stroke 25.22 14.24 19 16565 13770 110558945
Systemic lupus erythematosus 25.16 14.24 4 16580 254334 110318381
Acute myocardial infarction 25.01 14.24 45 16539 83732 110488983
Urine ketone body present 25.00 14.24 12 16572 3834 110568881
Blood lactate dehydrogenase increased 24.95 14.24 32 16552 44302 110528413
Femoral neck fracture 24.51 14.24 18 16566 12549 110560166
Embolic cerebral infarction 24.40 14.24 9 16575 1497 110571218
Toxicity to various agents 24.04 14.24 22 16562 480533 110092182
Pancreatic carcinoma 23.94 14.24 19 16565 14853 110557862
Erythema multiforme 23.84 14.24 22 16562 21075 110551640
Therapeutic product effect decreased 23.81 14.24 4 16580 244312 110328403
Joint swelling 23.70 14.24 19 16565 442826 110129889
Lower respiratory tract infection 23.65 14.24 4 16580 243102 110329613
Completed suicide 23.55 14.24 4 16580 242377 110330338
Hypersensitivity 23.34 14.24 16 16568 403982 110168733
Pyelonephritis 22.29 14.24 23 16561 25227 110547488
Cerebral haemorrhage 22.14 14.24 37 16547 64931 110507784
Hyperkalaemia 22.07 14.24 57 16527 135739 110436976
General physical health deterioration 21.83 14.24 19 16565 425276 110147439
Swelling 21.51 14.24 13 16571 351028 110221687
Immobilisation syndrome 20.96 14.24 7 16577 869 110571846
Dyslipidaemia 20.71 14.24 18 16566 15947 110556768
Blood pressure decreased 20.48 14.24 50 16534 115041 110457674
Anorgasmia 20.08 14.24 8 16576 1638 110571077
Diabetic ketoacidosis 20.06 14.24 28 16556 42030 110530685
Neutrophil count decreased 19.90 14.24 51 16533 120890 110451825
Diverticulum intestinal haemorrhagic 19.80 14.24 11 16573 4752 110567963
Blood triglycerides increased 19.70 14.24 21 16563 23905 110548810
Hyperglycaemia 19.64 14.24 41 16543 85049 110487666
Wheezing 19.41 14.24 7 16577 255223 110317492
Alopecia 19.08 14.24 16 16568 364737 110207978
Pulmonary sepsis 18.74 14.24 11 16573 5267 110567448
Spinal compression fracture 18.53 14.24 18 16566 18374 110554341
Off label use 18.31 14.24 141 16443 1500044 109072671
Vulvovaginal inflammation 17.98 14.24 6 16578 743 110571972
Gingival oedema 17.95 14.24 4 16580 107 110572608
Myocardial infarction 17.57 14.24 66 16518 192017 110380698
Diabetes mellitus inadequate control 17.56 14.24 22 16562 29753 110542962
Toxic encephalopathy 17.45 14.24 16 16568 15198 110557517
Muscle spasms 17.28 14.24 85 16499 278072 110294643
Gamma-glutamyltransferase increased 17.12 14.24 32 16552 61277 110511438
Bile duct stone 16.97 14.24 11 16573 6278 110566437
Intentional product use issue 16.91 14.24 8 16576 247898 110324817
Cardiac failure chronic 16.78 14.24 15 16569 13796 110558919
Bronchitis chronic 16.77 14.24 10 16574 4930 110567785
Renal disorder 16.62 14.24 28 16556 49451 110523264
Angina unstable 16.40 14.24 16 16568 16416 110556299
Gastric dysplasia 16.32 14.24 3 16581 29 110572686
Cardio-respiratory arrest 16.19 14.24 46 16538 115790 110456925
Tinnitus 16.16 14.24 31 16553 60509 110512206
Pemphigus 16.12 14.24 6 16578 214564 110358151
Disseminated intravascular coagulation 16.10 14.24 25 16559 41261 110531454
Glucose-6-phosphate dehydrogenase deficiency 16.07 14.24 5 16579 496 110572219
Rheumatoid arthritis 15.84 14.24 13 16571 299600 110273115
Folliculitis 15.78 14.24 3 16581 167650 110405065
Blood urea increased 15.74 14.24 29 16555 54928 110517787
Psoriatic arthropathy 15.65 14.24 5 16579 196756 110375959
Generalised oedema 15.48 14.24 21 16563 30683 110542032
Thalamus haemorrhage 15.47 14.24 7 16577 1957 110570758
Irritable bowel syndrome 15.32 14.24 3 16581 164212 110408503
Bladder cancer 15.30 14.24 17 16567 20275 110552440
Infusion related reaction 15.17 14.24 21 16563 381141 110191574
Injury 15.02 14.24 4 16580 177261 110395454
Radiation pneumonitis 14.93 14.24 9 16575 4527 110568188
Vessel puncture site haematoma 14.69 14.24 4 16580 248 110572467
Head discomfort 14.46 14.24 16 16568 18984 110553731
Hypothyroidism 14.41 14.24 33 16551 72866 110499849
Diabetic nephropathy 14.30 14.24 8 16576 3500 110569215

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AA08 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
HMG CoA reductase inhibitors
ATC C10BA13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
FDA MoA N0000000121 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000175589 HMG-CoA Reductase Inhibitor
CHEBI has role CHEBI:22586 antioxidant
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

C10AA HMG CoA reductase inhibitors 7 drugs
C10BA Combinations of various lipid modifying agents 9 drugs

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

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Mixed hyperlipidemia indication 267434003
Familial hypercholesterolemia indication 398036000 DOID:13810
Dehydration contraindication 34095006
Hypothyroidism contraindication 40930008 DOID:1459
Low blood pressure contraindication 45007003
Acute infectious disease contraindication 63171007
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Impaired renal function disorder contraindication 197663003
Hemorrhagic cerebral infarction contraindication 230706003
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
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 levelDissociation constantType (acidic/basic)
pKa1 4.05 acidic
pKa2 13.01 acidic
pKa3 13.99 acidic
pKa4 5.11 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme INHIBITOR IC50 8.17 WOMBAT-PK CHEMBL
Retinoic acid receptor RXR-alpha Nuclear hormone receptor Kd 4.88 CHEMBL
Nuclear receptor subfamily 4 group A member 2 Nuclear other EC50 6.92 CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme IC50 4.98 CHEMBL

External reference:

IDSource
4029463 VUID
N0000180308 NUI
D01862 KEGG_DRUG
147526-32-7 SECONDARY_CAS_RN
4029463 VANDF
4037418 VANDF
C1101838 UMLSCUI
CHEBI:32020 CHEBI
PV9 PDB_CHEM_ID
CHEMBL1201753 ChEMBL_ID
CHEMBL1237061 ChEMBL_ID
DB08860 DRUGBANK_ID
C108475 MESH_SUPPLEMENTAL_RECORD_UI
5282452 PUBCHEM_CID
3035 IUPHAR_LIGAND_ID
7730 INN_ID
M5681Q5F9P UNII
861612 RXNORM
173089 MMSL
27200 MMSL
33902 MMSL
372947 MMSL
d07637 MMSL
013206 NDDF
013429 NDDF
443585001 SNOMEDCT_US
443586000 SNOMEDCT_US
700402009 SNOMEDCT_US
M5681Q5F9P INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pitavastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0378-5055 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
Pitavastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0378-5056 TABLET, FILM COATED 2 mg ORAL ANDA 26 sections
Pitavastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0378-5057 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0480-3631 TABLET, FILM COATED 1.05 mg ORAL ANDA 17 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0480-3632 TABLET, FILM COATED 2.09 mg ORAL ANDA 17 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0480-3633 TABLET, FILM COATED 4.18 mg ORAL ANDA 17 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0832-6048 TABLET 1 mg ORAL ANDA 30 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0832-6049 TABLET 2 mg ORAL ANDA 30 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 0832-6050 TABLET 4 mg ORAL ANDA 30 sections
ZYPITAMAG HUMAN PRESCRIPTION DRUG LABEL 1 25208-201 TABLET, FILM COATED 2 mg ORAL NDA 26 sections
ZYPITAMAG HUMAN PRESCRIPTION DRUG LABEL 1 25208-202 TABLET, FILM COATED 4 mg ORAL NDA 26 sections
pitavastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 31722-875 TABLET, FILM COATED 1.05 mg ORAL ANDA 26 sections
pitavastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 31722-876 TABLET, FILM COATED 2.09 mg ORAL ANDA 26 sections
pitavastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 31722-877 TABLET, FILM COATED 4.18 mg ORAL ANDA 26 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 42291-905 TABLET, FILM COATED 1.05 mg ORAL ANDA 18 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 42291-906 TABLET, FILM COATED 2.09 mg ORAL ANDA 18 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 42291-907 TABLET, FILM COATED 4.18 mg ORAL ANDA 18 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 51407-956 TABLET 1 mg ORAL ANDA 30 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 51407-957 TABLET 2 mg ORAL ANDA 30 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 51407-958 TABLET 4 mg ORAL ANDA 30 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 65162-029 TABLET, FILM COATED 1 mg ORAL ANDA 23 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 65162-030 TABLET, FILM COATED 2 mg ORAL ANDA 23 sections
Pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 65162-031 TABLET, FILM COATED 4 mg ORAL ANDA 23 sections
Pitavastatin Human Prescription Drug Label 1 65862-812 TABLET, FILM COATED 1 mg ORAL ANDA 25 sections
Pitavastatin Human Prescription Drug Label 1 65862-813 TABLET, FILM COATED 2 mg ORAL ANDA 25 sections
Pitavastatin Human Prescription Drug Label 1 65862-814 TABLET, FILM COATED 4 mg ORAL ANDA 25 sections
Livalo HUMAN PRESCRIPTION DRUG LABEL 1 66869-104 TABLET, FILM COATED 1.05 mg ORAL NDA 30 sections
Livalo HUMAN PRESCRIPTION DRUG LABEL 1 66869-204 TABLET, FILM COATED 2.09 mg ORAL NDA 30 sections
Livalo HUMAN PRESCRIPTION DRUG LABEL 1 66869-404 TABLET, FILM COATED 4.18 mg ORAL NDA 30 sections
pitavastatin HUMAN PRESCRIPTION DRUG LABEL 1 68180-735 TABLET, FILM COATED 1 mg ORAL ANDA 24 sections