simvastatin Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors 2445 79902-63-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • simvastatin
  • sinvacor
  • simvastol
A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.
  • Molecular weight: 418.57
  • Formula: C25H38O5
  • CLOGP: 4.48
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 72.83
  • ALOGS: -4.53
  • ROTB: 7

Drug dosage:

DoseUnitRoute
30 mg O
30 mg O

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 1991 FDA MERCK

FDA Adverse Event Reporting System

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
Rhabdomyolysis 9220.49 36.58 2060 12116 17498 4607318
Myalgia 5836.69 36.58 1671 12505 40377 4584439
Drug interaction 3850.71 36.58 1351 12825 63157 4561659
Blood creatine phosphokinase increased 3164.26 36.58 835 13341 14264 4610552
Acute kidney injury 2637.09 36.58 1051 13125 69380 4555436
Myopathy 2271.35 36.58 490 13686 3248 4621568
Muscular weakness 1742.81 36.58 601 13575 25949 4598867
Completed suicide 1118.04 36.58 496 13680 41949 4582867
Pain in extremity 1078.71 36.58 549 13627 63190 4561626
Muscle spasms 1045.69 36.58 449 13727 35041 4589775
Myositis 1009.58 36.58 246 13930 2927 4621889
Asthenia 850.74 36.58 521 13655 85642 4539174
Tendon rupture 801.74 36.58 209 13967 3317 4621499
Alanine aminotransferase increased 750.21 36.58 333 13843 28040 4596776
Arthralgia 723.54 36.58 462 13714 81532 4543284
Fatigue 679.91 36.58 557 13619 145009 4479807
Liver function test abnormal 666.69 36.58 254 13922 14438 4610378
Drug hypersensitivity 601.68 36.58 385 13791 68015 4556801
Dyspnoea 516.04 36.58 467 13709 138518 4486298
Fall 494.96 36.58 359 13817 77687 4547129
Toxicity to various agents 492.70 36.58 347 13829 71693 4553123
Gait disturbance 480.20 36.58 267 13909 36373 4588443
Confusional state 459.06 36.58 287 13889 48547 4576269
Chromaturia 449.23 36.58 149 14027 5612 4619204
Aspartate aminotransferase increased 429.07 36.58 218 13958 24720 4600096
Immune-mediated myositis 420.87 36.58 86 14090 413 4624403
Quality of life decreased 418.54 36.58 104 14072 1342 4623474
Amnesia 384.20 36.58 165 14011 12756 4612060
Dizziness 372.45 36.58 337 13839 99534 4525282
Malaise 367.51 36.58 320 13856 89837 4534979
Nightmare 362.80 36.58 134 14042 6956 4617860
Pain 361.29 36.58 321 13855 92549 4532267
Muscle atrophy 356.99 36.58 102 14074 2305 4622511
Hypotension 355.59 36.58 278 13898 67122 4557694
Drug-induced liver injury 355.35 36.58 139 14037 8452 4616364
Balance disorder 347.89 36.58 165 14011 16091 4608725
Blood creatinine increased 343.86 36.58 193 13983 26707 4598109
Depression 339.90 36.58 236 13940 47497 4577319
Muscle rupture 333.94 36.58 79 14097 816 4624000
Oedema peripheral 330.82 36.58 221 13955 41751 4583065
Hepatic enzyme increased 329.01 36.58 164 14012 17827 4606989
Psychiatric symptom 313.27 36.58 87 14089 1766 4623050
Weight decreased 311.93 36.58 236 13940 54228 4570588
Renal failure 281.46 36.58 199 13977 41170 4583646
Decreased appetite 280.84 36.58 225 13951 56172 4568644
Hyperkalaemia 276.69 36.58 140 14036 15697 4609119
Back pain 275.91 36.58 213 13963 50386 4574430
Labelled drug-drug interaction medication error 274.83 36.58 89 14087 3099 4621717
Insomnia 271.79 36.58 202 13974 45143 4579673
Paraesthesia 269.54 36.58 182 13994 34951 4589865
Drug intolerance 266.92 36.58 152 14024 21594 4603222
Tenderness 266.04 36.58 86 14090 2977 4621839
Overdose 260.94 36.58 194 13982 43365 4581451
Gait inability 259.54 36.58 115 14061 9570 4615246
Chest pain 258.19 36.58 205 13971 50495 4574321
Headache 256.10 36.58 303 13873 122070 4502746
Mobility decreased 255.09 36.58 125 14051 13080 4611736
Diarrhoea 252.29 36.58 333 13843 149852 4474964
Pulmonary fibrosis 243.04 36.58 94 14082 5536 4619280
Rash 242.78 36.58 278 13898 108110 4516706
Nausea 242.38 36.58 356 13820 176977 4447839
Intentional overdose 240.21 36.58 142 14034 21624 4603192
Self esteem decreased 235.85 36.58 50 14126 296 4624520
Actinic keratosis 235.61 36.58 62 14114 1017 4623799
Jaundice 234.73 36.58 116 14060 12358 4612458
Pancreatitis acute 223.15 36.58 100 14076 8543 4616273
Impaired work ability 222.94 36.58 75 14101 2945 4621871
Truncus arteriosus persistent 221.18 36.58 38 14138 49 4624767
General physical health deterioration 220.45 36.58 149 14027 28629 4596187
Atrial fibrillation 218.79 36.58 153 14023 31062 4593754
Cough 217.32 36.58 193 13983 55394 4569422
Transaminases increased 216.14 36.58 101 14075 9505 4615311
Lethargy 212.82 36.58 121 14055 17120 4607696
Abdominal pain 212.31 36.58 197 13979 59827 4564989
Vomiting 210.99 36.58 272 13904 119427 4505389
Renal impairment 208.05 36.58 137 14039 25201 4599615
Interstitial lung disease 205.42 36.58 123 14053 19162 4605654
Necrotising myositis 202.32 36.58 38 14138 105 4624711
Hepatitis 201.81 36.58 104 14072 12101 4612715
Pruritus 200.38 36.58 208 13968 72364 4552452
Hypoaesthesia 198.44 36.58 145 14031 31520 4593296
Tendonitis 196.66 36.58 73 14103 3835 4620981
Sleep disorder 194.99 36.58 99 14077 11164 4613652
Syncope 193.76 36.58 146 14030 33249 4591567
Haemodialysis 191.21 36.58 76 14100 4811 4620005
International normalised ratio increased 190.45 36.58 112 14064 16876 4607940
Cognitive disorder 189.87 36.58 95 14081 10386 4614430
Memory impairment 188.91 36.58 119 14057 20284 4604532
Hepatotoxicity 185.89 36.58 87 14089 8212 4616604
Autoimmune hepatitis 184.69 36.58 63 14113 2581 4622235
Musculoskeletal pain 182.38 36.58 108 14068 16480 4608336
Dermatomyositis 181.95 36.58 47 14129 714 4624102
Somnolence 179.38 36.58 156 14020 43504 4581312
Anuria 173.13 36.58 67 14109 3948 4620868
Social problem 170.15 36.58 39 14137 346 4624470
Polymyositis 169.87 36.58 44 14132 676 4624140
Muscle necrosis 168.86 36.58 39 14137 359 4624457
Dysphagia 166.95 36.58 120 14056 25411 4599405
Feeling abnormal 165.72 36.58 138 14038 36267 4588549
Dehydration 163.50 36.58 146 14030 42144 4582672
Social avoidant behaviour 161.89 36.58 48 14128 1238 4623578
Blood bilirubin increased 159.34 36.58 90 14086 12562 4612254
Hyperhidrosis 158.61 36.58 124 14052 29793 4595023
Gamma-glutamyltransferase increased 158.01 36.58 86 14090 11168 4613648
Haematuria 157.26 36.58 90 14086 12880 4611936
Colitis microscopic 156.27 36.58 48 14128 1400 4623416
Liver injury 155.76 36.58 66 14110 4919 4619897
Blood alkaline phosphatase increased 154.90 36.58 88 14088 12419 4612397
Abdominal distension 154.29 36.58 100 14076 17889 4606927
Polyneuropathy 154.07 36.58 61 14115 3820 4620996
Sepsis 154.04 36.58 142 14034 42697 4582119
Myocardial infarction 153.48 36.58 151 14025 49225 4575591
Loss of personal independence in daily activities 151.32 36.58 75 14101 8030 4616786
Lymphatic fistula 146.79 36.58 23 14153 7 4624809
Femoral hernia incarcerated 146.03 36.58 23 14153 8 4624808
Hyponatraemia 145.34 36.58 109 14067 24621 4600195
Movement disorder 145.10 36.58 62 14114 4717 4620099
Abnormal dreams 145.05 36.58 62 14114 4721 4620095
Acute hepatic failure 144.49 36.58 65 14111 5597 4619219
Loss of consciousness 143.49 36.58 126 14050 35556 4589260
Frustration tolerance decreased 142.99 36.58 44 14132 1291 4623525
Metabolic acidosis 141.98 36.58 83 14093 12357 4612459
Blood urea increased 140.13 36.58 73 14103 8677 4616139
Acute respiratory distress syndrome 138.71 36.58 69 14107 7444 4617372
Abnormal loss of weight 138.64 36.58 43 14133 1296 4623520
Myoglobin blood increased 137.63 36.58 38 14138 753 4624063
Dyspnoea exertional 137.32 36.58 76 14100 10196 4614620
Dyspepsia 137.06 36.58 89 14087 15965 4608851
Suicide attempt 136.31 36.58 98 14078 20744 4604072
Disturbance in attention 135.21 36.58 76 14100 10505 4614311
Compartment syndrome 134.88 36.58 40 14136 1032 4623784
Contraindicated product administered 134.20 36.58 60 14116 5091 4619725
Cardiac arrest 132.57 36.58 118 14058 33889 4590927
Cardiac failure 131.58 36.58 107 14069 27181 4597635
Cardio-respiratory arrest 131.46 36.58 94 14082 19728 4605088
Pneumonia 130.72 36.58 200 13976 102615 4522201
Pancreatitis necrotising 130.16 36.58 36 14140 718 4624098
Abdominal pain upper 129.31 36.58 118 14058 34997 4589819
Blood cholesterol increased 129.11 36.58 69 14107 8637 4616179
Hepatomegaly 128.88 36.58 53 14123 3662 4621154
Renal tubular necrosis 128.20 36.58 54 14122 3964 4620852
Pancreatitis 124.46 36.58 86 14090 17092 4607724
Myoglobinuria 124.40 36.58 29 14147 279 4624537
Erectile dysfunction 122.48 36.58 55 14121 4714 4620102
Aggression 120.97 36.58 78 14098 13821 4610995
Myasthenia gravis 120.83 36.58 39 14137 1341 4623475
Bradycardia 120.56 36.58 94 14082 22475 4602341
Pancreatic steatosis 120.07 36.58 23 14153 73 4624743
Congenital cardiovascular anomaly 119.22 36.58 28 14148 279 4624537
Pyrexia 119.07 36.58 196 13980 106948 4517868
Hepatic cyst 118.72 36.58 36 14140 1004 4623812
Dermatitis exfoliative 118.15 36.58 47 14129 2979 4621837
Mitochondrial myopathy 117.79 36.58 23 14153 83 4624733
Urinary tract infection 117.69 36.58 122 14054 42268 4582548
Potentiating drug interaction 117.11 36.58 39 14137 1482 4623334
Hypoglycaemia 116.81 36.58 85 14091 18324 4606492
Palpitations 116.78 36.58 96 14080 24750 4600066
Basal cell carcinoma 116.47 36.58 56 14120 5608 4619208
Bowen's disease 115.76 36.58 31 14145 545 4624271
Cerebrovascular accident 115.03 36.58 120 14056 41880 4582936
Swollen tongue 114.92 36.58 64 14112 8686 4616130
Ventricular septal defect 114.49 36.58 43 14133 2332 4622484
Lichenoid keratosis 113.78 36.58 33 14143 786 4624030
Hepatic function abnormal 113.43 36.58 76 14100 14360 4610456
Condition aggravated 112.97 36.58 139 14037 58032 4566784
Musculoskeletal stiffness 112.56 36.58 84 14092 18818 4605998
Wrong patient received product 112.21 36.58 30 14146 524 4624292
Wound infection pseudomonas 112.07 36.58 23 14153 113 4624703
Oliguria 111.61 36.58 44 14132 2723 4622093
Tachycardia 111.42 36.58 103 14073 31042 4593774
Personality change 110.06 36.58 41 14135 2173 4622643
Respiratory arrest 108.69 36.58 72 14104 13348 4611468
Dialysis 108.57 36.58 51 14125 4848 4619968
Blood urine present 107.56 36.58 48 14128 4053 4620763
Angioedema 107.03 36.58 83 14093 19682 4605134
Irritability 106.86 36.58 71 14105 13228 4611588
Acute myocardial infarction 106.17 36.58 73 14103 14386 4610430
Contusion 104.57 36.58 81 14095 19177 4605639
Cholestasis 104.21 36.58 58 14118 7862 4616954
Tremor 103.60 36.58 106 14070 36153 4588663
Myocardial depression 102.53 36.58 21 14155 102 4624714
Cardiac septal defect 101.26 36.58 23 14153 195 4624621
White blood cell count increased 100.29 36.58 72 14104 15195 4609621
Inhibitory drug interaction 100.28 36.58 28 14148 579 4624237
Tinnitus 99.12 36.58 59 14117 9074 4615742
Peripheral swelling 98.82 36.58 90 14086 26602 4598214
Aplastic anaemia 98.36 36.58 36 14140 1815 4623001
Mitral valve incompetence 97.98 36.58 47 14129 4681 4620135
Arterial haemorrhage 96.56 36.58 25 14151 383 4624433
Swelling face 95.22 36.58 69 14107 14771 4610045
Urinary retention 95.02 36.58 59 14117 9788 4615028
Hypercholesterolaemia 94.60 36.58 40 14136 2963 4621853
Vision blurred 94.51 36.58 85 14091 24718 4600098
Cutaneous T-cell dyscrasia 93.97 36.58 15 14161 7 4624809
Angina pectoris 93.95 36.58 58 14118 9523 4615293
Inflammatory marker increased 93.94 36.58 30 14146 996 4623820
Dysstasia 93.87 36.58 46 14130 4801 4620015
High density lipoprotein decreased 93.81 36.58 31 14145 1149 4623667
Muscle disorder 93.66 36.58 33 14143 1489 4623327
Myopathy toxic 92.45 36.58 22 14154 233 4624583
Cardiovascular disorder 92.21 36.58 48 14128 5692 4619124
Carotid arteriosclerosis 91.37 36.58 23 14153 313 4624503
Decorticate posture 91.31 36.58 17 14159 44 4624772
Quadriparesis 91.16 36.58 26 14150 582 4624234
Blood lactate dehydrogenase increased 90.10 36.58 52 14124 7551 4617265
Hypothermia 89.56 36.58 43 14133 4291 4620525
Hypertension 88.46 36.58 115 14061 50683 4574133
Anxiety 87.22 36.58 111 14065 47900 4576916
Naevus flammeus 87.14 36.58 17 14159 61 4624755
Photosensitivity reaction 86.90 36.58 43 14133 4583 4620233
Suicidal ideation 86.27 36.58 76 14100 21507 4603309
Skin cancer 85.99 36.58 39 14137 3420 4621396
Blood potassium increased 85.85 36.58 44 14132 5051 4619765
Vertigo 85.77 36.58 65 14111 14891 4609925
Blood pressure increased 85.73 36.58 87 14089 29373 4595443
Hepatitis acute 84.85 36.58 37 14139 2955 4621861
Poisoning 84.79 36.58 46 14130 5928 4618888
Seroma 84.05 36.58 23 14153 440 4624376
Hepatic failure 84.05 36.58 61 14115 13088 4611728
Discomfort 83.59 36.58 51 14125 8199 4616617
Cardiogenic shock 83.46 36.58 44 14132 5354 4619462
Gout 83.19 36.58 41 14135 4332 4620484
Abdominal discomfort 82.86 36.58 84 14092 28324 4596492
Cerebral haemorrhage 82.85 36.58 61 14115 13380 4611436
Paralysis 82.84 36.58 38 14138 3421 4621395
Eructation 82.24 36.58 32 14144 1911 4622905
Anaemia 82.20 36.58 133 14043 71427 4553389
Swelling 81.84 36.58 78 14098 24404 4600412
Groin pain 81.64 36.58 33 14143 2180 4622636
Diabetes mellitus 81.54 36.58 64 14112 15437 4609379
Blood albumin decreased 81.24 36.58 38 14138 3576 4621240
C-reactive protein increased 80.90 36.58 59 14117 12753 4612063
Aortic valve stenosis 80.78 36.58 24 14152 623 4624193
Anal incontinence 80.04 36.58 36 14140 3095 4621721
Foetal exposure during pregnancy 79.71 36.58 75 14101 23094 4601722
Dysarthria 78.34 36.58 57 14119 12275 4612541
Haemoglobin decreased 77.96 36.58 93 14083 37564 4587252
Faeces pale 77.67 36.58 23 14153 590 4624226
Liver disorder 77.49 36.58 58 14118 13040 4611776
Heart disease congenital 77.34 36.58 27 14149 1185 4623631
Aortic arteriosclerosis 77.08 36.58 27 14149 1197 4623619
Neck pain 77.05 36.58 55 14121 11497 4613319
Product prescribing error 76.87 36.58 46 14130 7140 4617676
Respiratory failure 76.52 36.58 83 14093 30243 4594573
Tachyarrhythmia 76.15 36.58 27 14149 1241 4623575
Electrocardiogram QT prolonged 75.85 36.58 61 14115 15234 4609582
Precancerous skin lesion 75.42 36.58 20 14156 338 4624478
Diverticulum intestinal 74.85 36.58 27 14149 1305 4623511
Haemarthrosis 73.66 36.58 26 14150 1179 4623637
Neutrophil count increased 73.43 36.58 39 14137 4816 4620000
Hypokalaemia 72.85 36.58 65 14111 18695 4606121
Hepatitis cholestatic 72.79 36.58 32 14144 2606 4622210
Muscle injury 72.63 36.58 22 14154 611 4624205
Acute coronary syndrome 72.47 36.58 37 14139 4213 4620603
Vasculitis 72.13 36.58 37 14139 4254 4620562
Unresponsive to stimuli 71.83 36.58 50 14126 10043 4614773
Flatulence 71.47 36.58 46 14130 8118 4616698
Low density lipoprotein increased 71.23 36.58 31 14145 2464 4622352
Asphyxia 71.07 36.58 30 14146 2212 4622604
Alveolitis 70.13 36.58 23 14153 832 4623984
Neuropathy peripheral 69.03 36.58 70 14106 23599 4601217
Listless 68.50 36.58 22 14154 744 4624072
Collagen disorder 68.43 36.58 16 14160 156 4624660
Left ventricular dysfunction 68.39 36.58 31 14145 2714 4622102
Treatment noncompliance 68.36 36.58 52 14124 11975 4612841
Medication error 68.33 36.58 56 14120 14360 4610456
Hiatus hernia 68.18 36.58 33 14143 3351 4621465
Granuloma annulare 68.18 36.58 17 14159 222 4624594
Escherichia infection 67.82 36.58 30 14146 2479 4622337
Muscle twitching 67.29 36.58 37 14139 4894 4619922
Coma scale abnormal 66.86 36.58 26 14150 1550 4623266
Areflexia 66.14 36.58 24 14152 1180 4623636
Ventricular hypokinesia 66.06 36.58 25 14151 1384 4623432
Alopecia 65.91 36.58 74 14102 28006 4596810
Gastrointestinal haemorrhage 65.82 36.58 77 14099 30458 4594358
Speech disorder 65.74 36.58 50 14126 11512 4613304
Depressed mood 65.73 36.58 45 14131 8799 4616017
Intentional self-injury 65.62 36.58 42 14134 7341 4617475
Joint dislocation 65.55 36.58 28 14148 2126 4622690
Wound dehiscence 65.48 36.58 25 14151 1418 4623398
Head injury 65.45 36.58 42 14134 7373 4617443
Hypersensitivity 65.33 36.58 86 14090 38335 4586481
Oesophageal perforation 65.15 36.58 17 14159 269 4624547
Amyotrophic lateral sclerosis 65.01 36.58 20 14156 586 4624230
Tricuspid valve incompetence 64.65 36.58 31 14145 3083 4621733
Muscle contractions involuntary 64.60 36.58 23 14153 1070 4623746
Faecaloma 64.54 36.58 26 14150 1702 4623114
Arteriosclerosis coronary artery 64.18 36.58 31 14145 3133 4621683
Circulatory collapse 63.58 36.58 42 14134 7743 4617073
Emotional distress 63.56 36.58 39 14137 6331 4618485
Premature baby 62.80 36.58 46 14130 10005 4614811
Cold sweat 62.71 36.58 33 14143 3998 4620818
Hypoxia 62.24 36.58 51 14125 13070 4611746
Toxic epidermal necrolysis 62.01 36.58 38 14138 6154 4618662
Hypersensitivity pneumonitis 61.97 36.58 21 14155 842 4623974
Pollakiuria 61.80 36.58 40 14136 7125 4617691
Guillain-Barre syndrome 60.82 36.58 25 14151 1724 4623092
Constipation 60.59 36.58 87 14089 42067 4582749
Lichen planus 60.37 36.58 20 14156 747 4624069
Haemoptysis 60.30 36.58 43 14133 8971 4615845
Drug ineffective 59.94 36.58 210 13966 185851 4438965
Contraindicated product prescribed 59.46 36.58 15 14161 206 4624610
Low birth weight baby 59.39 36.58 28 14148 2682 4622134
Oesophageal obstruction 58.67 36.58 15 14161 218 4624598
Postoperative wound infection 57.64 36.58 25 14151 1970 4622846
Nodular rash 57.46 36.58 13 14163 108 4624708
Enteritis 57.38 36.58 26 14150 2274 4622542
Skin exfoliation 57.35 36.58 45 14131 10842 4613974
Blood pressure abnormal 57.28 36.58 28 14148 2905 4621911
Exercise tolerance decreased 56.94 36.58 22 14154 1289 4623527
Hepatic enzyme abnormal 56.85 36.58 22 14154 1294 4623522
Abortion induced 56.62 36.58 31 14145 4066 4620750
Lower respiratory tract infection 56.30 36.58 43 14133 9960 4614856
Postprandial hypoglycaemia 56.18 36.58 10 14166 18 4624798
Burning sensation 56.01 36.58 46 14130 11826 4612990
Hepatocellular injury 55.89 36.58 39 14137 7861 4616955
Chest discomfort 55.89 36.58 62 14114 23148 4601668
Limb discomfort 55.84 36.58 33 14143 5005 4619811
Sopor 55.22 36.58 36 14140 6490 4618326
Bezoar 55.16 36.58 16 14160 381 4624435
Tendon disorder 54.92 36.58 22 14154 1419 4623397
Thrombotic thrombocytopenic purpura 54.90 36.58 23 14153 1664 4623152
Weight increased 54.78 36.58 77 14099 36504 4588312
Pemphigus 54.75 36.58 20 14156 1002 4623814
Apolipoprotein A-I decreased 54.65 36.58 9 14167 7 4624809
Joint swelling 54.03 36.58 62 14114 24016 4600800
Ocular myasthenia 53.78 36.58 12 14164 93 4624723
Lactic acidosis 53.65 36.58 45 14131 11911 4612905
Osteopenia 53.64 36.58 26 14150 2648 4622168
Hepatic necrosis 53.52 36.58 24 14152 2048 4622768
Myoglobin urine 53.10 36.58 9 14167 10 4624806
Myelofibrosis 52.64 36.58 20 14156 1119 4623697
Product substitution issue 52.32 36.58 40 14136 9278 4615538
Neuropathy, ataxia, retinitis pigmentosa syndrome 52.23 36.58 8 14168 1 4624815
Aphasia 51.80 36.58 39 14137 8841 4615975
Coma 51.42 36.58 52 14124 17467 4607349
Impaired healing 51.16 36.58 38 14138 8441 4616375
Impaired quality of life 51.02 36.58 15 14161 375 4624441
Immobile 50.81 36.58 19 14157 1017 4623799
Blood glucose increased 50.43 36.58 60 14116 24144 4600672
Ejaculation failure 50.42 36.58 15 14161 391 4624425
Dysuria 50.40 36.58 37 14139 8073 4616743
Visual impairment 50.36 36.58 54 14122 19406 4605410
Renal disorder 49.84 36.58 39 14137 9357 4615459
Coronary artery disease 49.09 36.58 49 14127 16203 4608613
Restless legs syndrome 49.01 36.58 27 14149 3584 4621232
Mood altered 48.95 36.58 31 14145 5318 4619498
Ubiquinone decreased 48.70 36.58 8 14168 6 4624810
Pulmonary hypertension 48.60 36.58 37 14139 8526 4616290
Myocardial ischaemia 48.58 36.58 32 14144 5870 4618946
Eczema 48.48 36.58 32 14144 5889 4618927
Erythema 48.16 36.58 78 14098 41862 4582954
Peripheral coldness 47.77 36.58 25 14151 2995 4621821
Gynaecomastia 47.54 36.58 23 14153 2332 4622484
Hyperlipidaemia 47.54 36.58 30 14146 5115 4619701
Coronary artery occlusion 47.53 36.58 26 14150 3403 4621413
Diastolic dysfunction 47.43 36.58 19 14157 1225 4623591
Eye swelling 47.23 36.58 33 14143 6664 4618152
Hepatic steatosis 47.01 36.58 32 14144 6196 4618620
Actinic elastosis 46.87 36.58 9 14167 29 4624787
Arrhythmia 46.62 36.58 44 14132 13588 4611228
Labile hypertension 46.09 36.58 11 14165 118 4624698
Musculoskeletal discomfort 45.78 36.58 25 14151 3261 4621555
Antineutrophil cytoplasmic antibody positive 45.74 36.58 12 14164 194 4624622
Splenomegaly 45.57 36.58 27 14149 4113 4620703
Dermatitis bullous 45.49 36.58 24 14152 2923 4621893
Periarthritis 45.33 36.58 15 14161 558 4624258
Muscle fatigue 45.21 36.58 16 14160 731 4624085
Acidosis 44.94 36.58 25 14151 3381 4621435
Partner stress 44.82 36.58 11 14165 134 4624682
Paraparesis 44.58 36.58 16 14160 762 4624054
Linear IgA disease 44.56 36.58 16 14160 763 4624053
Pneumonia aspiration 44.51 36.58 37 14139 9669 4615147
Blood triglycerides increased 44.14 36.58 29 14147 5296 4619520
Left ventricular failure 43.70 36.58 19 14157 1506 4623310
Haemorrhage intracranial 43.67 36.58 33 14143 7521 4617295
Peroneal nerve palsy 43.28 36.58 18 14158 1278 4623538
Multiple organ dysfunction syndrome 43.26 36.58 49 14127 18707 4606109
Food interaction 42.99 36.58 14 14162 495 4624321
Cerebral infarction 42.97 36.58 38 14138 10794 4614022
Electrocardiogram ST segment elevation 42.53 36.58 19 14157 1607 4623209
Chronic obstructive pulmonary disease 42.42 36.58 42 14134 13752 4611064
Hepatitis E 42.36 36.58 14 14162 519 4624297
Neuromyopathy 42.15 36.58 13 14163 384 4624432
Pleurisy 42.01 36.58 21 14155 2285 4622531
Avoidant personality disorder 41.20 36.58 7 14169 8 4624808
Product complaint 40.95 36.58 32 14144 7662 4617154
Polymyalgia rheumatica 40.79 36.58 15 14161 766 4624050
Defaecation urgency 40.79 36.58 15 14161 766 4624050
Drug eruption 40.75 36.58 30 14146 6573 4618243
Night sweats 40.35 36.58 29 14147 6122 4618694
Disorientation 40.30 36.58 39 14137 12420 4612396
Lipohypertrophy 40.27 36.58 11 14165 209 4624607
Hemiplegia 40.21 36.58 22 14154 2881 4621935
Occupational problem environmental 39.92 36.58 7 14169 11 4624805
Poor quality sleep 39.88 36.58 23 14153 3332 4621484
Blood pH decreased 39.85 36.58 16 14160 1038 4623778
Arterial stenosis 39.66 36.58 12 14164 332 4624484
Disseminated intravascular coagulation 39.60 36.58 31 14145 7442 4617374
Transient global amnesia 39.46 36.58 11 14165 226 4624590
Extrasystoles 39.40 36.58 19 14157 1913 4622903
Hyporeflexia 39.21 36.58 15 14161 855 4623961
Depressed level of consciousness 39.12 36.58 42 14134 15112 4609704
Systemic lupus erythematosus 39.02 36.58 27 14149 5369 4619447
Inflammation 38.99 36.58 35 14141 10136 4614680
Eyelid ptosis 38.62 36.58 19 14157 1998 4622818
Blood pressure decreased 38.32 36.58 45 14131 17855 4606961
Hypothyroidism 38.17 36.58 31 14145 7843 4616973
Motor neurone disease 38.10 36.58 10 14166 162 4624654
Rash papular 37.95 36.58 25 14151 4586 4620230
Urosepsis 37.92 36.58 23 14153 3656 4621160
Scrotal oedema 37.72 36.58 11 14165 267 4624549
Drug abuse 37.70 36.58 56 14120 27891 4596925
Nocturia 37.43 36.58 19 14157 2136 4622680
Poliomyelitis 37.09 36.58 7 14169 20 4624796
Hand-eye coordination impaired 36.84 36.58 7 14169 21 4624795
Mental status changes 36.79 36.58 37 14139 12339 4612477
Myelodysplastic syndrome 36.79 36.58 29 14147 7029 4617787
Ataxia 36.77 36.58 26 14150 5351 4619465

Pharmacologic Action:

SourceCodeDescription
ATC C10AA01 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
HMG CoA reductase inhibitors
ATC A10BH51 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC C10BA02 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors in combination with other lipid modifying agents
ATC C10BA04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors in combination with other lipid modifying agents
ATC C10BX01 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
FDA EPC N0000175589 HMG-CoA Reductase Inhibitor
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:50266 prodrug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Arteriosclerotic vascular disease indication 72092001
Hypoalphalipoproteinemia indication 190785000
Cerebrovascular accident indication 230690007
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006
Familial type 3 hyperlipoproteinemia indication 398796005 DOID:3145
Prevention of Transient Ischemic Attacks indication
Myocardial Infarction Prevention indication
Slow Progression of Coronary Artery Disease indication
Myocardial Reinfarction Prevention off-label use
Primary Prevention of Coronary Heart Disease off-label use
Hypophosphatemia contraindication 4996001
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Myocardial infarction contraindication 22298006 DOID:5844
Low blood pressure contraindication 45007003
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Gout contraindication 90560007 DOID:13189
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Hemorrhagic cerebral infarction contraindication 230706003
Arterial hemorrhage contraindication 234003006
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Surgical procedure contraindication 387713003
Acute coronary syndrome contraindication 394659003
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myopathy related to SLCO1B1 Gene Variant contraindication
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance contraindication

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE

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 7.77 WOMBAT-PK CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
3-hydroxy-3-methylglutaryl-coenzyme A reductase Unclassified IC50 4.02 CHEMBL
Acetylcholinesterase Enzyme Ki 5.74 CHEMBL
Cholinesterase Enzyme Ki 6.12 CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme IC50 8.37 CHEMBL

External reference:

IDSource
4020400 VUID
N0000148200 NUI
C0074554 UMLSCUI
D00434 KEGG_DRUG
96304005 SNOMEDCT_US
4020400 VANDF
82969 MMSL
003621 NDDF
36567 RXNORM
387584000 SNOMEDCT_US
5465 MMSL
d00746 MMSL
AGG2FN16EV UNII
6147 INN_ID
CHEMBL1064 ChEMBL_ID
DB00641 DRUGBANK_ID
CHEBI:9150 CHEBI
D019821 MESH_DESCRIPTOR_UI
54454 PUBCHEM_CID
2955 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0543 TABLET, FILM COATED 80 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0726 TABLET, FILM COATED 5 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0735 TABLET, FILM COATED 10 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0740 TABLET, FILM COATED 20 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0749 TABLET, FILM COATED 40 mg ORAL NDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7152 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7153 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7154 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7155 TABLET, FILM COATED 40 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7156 TABLET, FILM COATED 80 mg ORAL ANDA 16 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1385 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1386 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1387 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1388 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6579 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6580 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6581 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6587 TABLET, FILM COATED 5 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6588 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7704 TABLET, FILM COATED 5 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7705 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7706 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7707 TABLET, FILM COATED 40 mg ORAL ANDA 17 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-7992 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-7993 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-8056 TABLET, FILM COATED 40 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-486 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-487 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-907 TABLET, FILM COATED 80 mg ORAL ANDA 17 sections
simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-908 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections