gemfibrozil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1285 25812-30-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • gemfibrosil
  • gemfibrozil
  • decrelip
  • lopizid
A lipid-regulating agent that lowers elevated serum lipids primarily by decreasing serum triglycerides with a variable reduction in total cholesterol.
  • Molecular weight: 250.34
  • Formula: C15H22O3
  • CLOGP: 3.94
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -3.95
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 79.89 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 98 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 21, 1981 FDA PFIZER PHARMS

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
Rhabdomyolysis 229.49 13.78 123 10236 40535 56241173
Drug hypersensitivity 71.83 13.78 157 10202 275048 56006660
Blood triglycerides increased 62.09 13.78 34 10325 11643 56270065
Coronary artery disease 56.07 13.78 46 10313 30750 56250958
Blood creatine phosphokinase increased 49.31 13.78 41 10318 27911 56253797
Myocardial infarction 48.78 13.78 72 10287 92798 56188910
Acute interstitial pneumonitis 43.16 13.78 12 10347 653 56281055
Cardiac failure congestive 37.68 13.78 62 10297 87658 56194050
Myalgia 37.42 13.78 78 10281 131947 56149761
Myopathy 37.35 13.78 23 10336 9789 56271919
Drug interaction 35.91 13.78 102 10257 209653 56072055
Cerebrovascular accident 34.61 13.78 64 10295 99206 56182502
Pancreatitis 31.27 13.78 40 10319 45040 56236668
Pancreatitis acute 28.90 13.78 29 10330 25095 56256613
Lip infection 28.57 13.78 6 10353 97 56281611
Rheumatoid arthritis 27.99 13.78 18 10341 382586 55899122
Hypertriglyceridaemia 25.68 13.78 15 10344 5801 56275907
Off label use 24.96 13.78 40 10319 556140 55725568
Drug intolerance 24.61 13.78 9 10350 264809 56016899
Blood glucose increased 24.38 13.78 47 10312 75104 56206604
Diabetes mellitus 22.26 13.78 37 10322 52698 56229010
Drug ineffective 20.79 13.78 93 10266 918896 55362812
Synovitis 19.84 13.78 3 10356 161302 56120406
Tendon rupture 19.71 13.78 14 10345 7556 56274152
Diabetes mellitus inadequate control 17.68 13.78 17 10342 13963 56267745
Hyperlipidaemia 17.42 13.78 19 10340 18090 56263618
Chronic kidney disease 17.07 13.78 29 10330 42027 56239681
Arthropathy 16.68 13.78 8 10351 200267 56081441
Infusion related reaction 16.42 13.78 9 10350 208922 56072786
Microalbuminuria 16.34 13.78 5 10354 381 56281327
Blood urea increased 15.85 13.78 21 10338 24452 56257256
Joint swelling 15.84 13.78 18 10341 289782 55991926
Bursitis 15.35 13.78 22 10337 27560 56254148
Bronchitis viral 15.22 13.78 6 10353 973 56280735
Infected bite 15.18 13.78 7 10352 1665 56280043
Maternal exposure during pregnancy 15.14 13.78 8 10351 189545 56092163
Angioedema 14.77 13.78 27 10332 41426 56240282
Transient ischaemic attack 14.76 13.78 24 10335 33553 56248155
Hypoglycaemia 14.66 13.78 32 10327 55783 56225925
Hypophagia 14.58 13.78 22 10337 28854 56252854
Blood creatine phosphokinase MB increased 14.19 13.78 6 10353 1163 56280545
Granulocytopenia 14.18 13.78 10 10349 5334 56276374
Wound 14.15 13.78 4 10355 138800 56142908
Myositis 14.06 13.78 12 10347 8456 56273252

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
Rhabdomyolysis 549.65 12.94 351 14429 63230 31619334
Acute kidney injury 114.80 12.94 337 14443 279377 31403187
Blood creatine phosphokinase increased 110.31 12.94 116 14664 41858 31640706
Blood triglycerides increased 107.96 12.94 71 14709 13326 31669238
Myalgia 99.00 12.94 149 14631 77109 31605455
Coronary artery disease 73.92 12.94 99 14681 45988 31636576
Myocardial infarction 61.66 12.94 152 14628 113302 31569262
Blood cholesterol increased 57.90 12.94 54 14726 16839 31665725
Drug hypersensitivity 56.07 12.94 112 14668 72487 31610077
Off label use 52.43 12.94 51 14729 347223 31335341
Polymyositis 52.34 12.94 21 14759 1394 31681170
Cardiac failure congestive 47.00 12.94 110 14670 79277 31603287
Drug interaction 40.38 12.94 198 14582 208345 31474219
Pancreatitis 37.48 12.94 63 14717 35708 31646856
International normalised ratio increased 30.46 12.94 66 14714 45157 31637407
Myopathy 30.27 12.94 31 14749 10821 31671743
Drug ineffective 28.05 12.94 93 14687 395480 31287084
Thunderclap headache 27.45 12.94 6 14774 43 31682521
Drug abuse 25.45 12.94 5 14775 87753 31594811
Hyperglycaemia 25.44 12.94 54 14726 36422 31646142
Chromaturia 25.11 12.94 31 14749 13267 31669297
Haemodialysis 25.00 12.94 27 14753 10018 31672546
Hypertriglyceridaemia 24.94 12.94 24 14756 7774 31674790
Chronic kidney disease 23.96 12.94 54 14726 37921 31644643
Granulocytopenia 23.84 12.94 21 14759 6078 31676486
Blood glucose increased 23.32 12.94 72 14708 61011 31621553
Drug level below therapeutic 23.04 12.94 19 14761 5029 31677535
Type 2 diabetes mellitus 21.03 12.94 30 14750 14754 31667810
General physical health deterioration 20.34 12.94 14 14766 113421 31569143
Myositis 19.57 12.94 25 14755 11069 31671495
Angina unstable 19.39 12.94 25 14755 11170 31671394
Angioedema 19.23 12.94 46 14734 33572 31648992
Blood glucose decreased 18.77 12.94 26 14754 12445 31670119
Erosive duodenitis 18.11 12.94 10 14770 1366 31681198
Product use in unapproved indication 18.09 12.94 12 14768 99159 31583405
Death 17.95 12.94 97 14683 360472 31322092
Treatment noncompliance 17.88 12.94 38 14742 25646 31656918
Hyperlipidaemia 17.69 12.94 26 14754 13134 31669430
Tricuspid valve incompetence 17.35 12.94 21 14759 8808 31673756
Lacrimation decreased 16.72 12.94 3 14777 6 31682558
Pyrexia 16.67 12.94 79 14701 303761 31378803
Iron deficiency anaemia 16.37 12.94 21 14759 9338 31673226
Fanconi syndrome 16.35 12.94 10 14770 1652 31680912
Muscular weakness 16.25 12.94 67 14713 65381 31617183
Asthenia 16.22 12.94 168 14612 224587 31457977
Blood creatinine increased 16.05 12.94 83 14697 88995 31593569
Reversible cerebral vasoconstriction syndrome 15.60 12.94 6 14774 356 31682208
Pneumonia haemophilus 15.47 12.94 6 14774 364 31682200
Otitis externa 15.05 12.94 8 14772 1013 31681551
Interstitial lung disease 14.93 12.94 5 14775 61398 31621166
Arteriosclerosis coronary artery 14.86 12.94 22 14758 11186 31671378
Chest pain 14.63 12.94 99 14681 116858 31565706
Metabolic acidosis 14.49 12.94 46 14734 39531 31643033
Breast neoplasm 14.48 12.94 3 14777 16 31682548
Renal tubular necrosis 14.14 12.94 25 14755 14734 31667830
Coronary artery stenosis 14.11 12.94 19 14761 8851 31673713
Hyperlactacidaemia 13.93 12.94 11 14769 2739 31679825
Intentional product use issue 13.91 12.94 3 14777 49344 31633220
Aortic valve sclerosis 13.74 12.94 7 14773 813 31681751
Paralysis 13.70 12.94 15 14765 5648 31676916
Supraventricular tachycardia 13.33 12.94 20 14760 10287 31672277

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
Rhabdomyolysis 726.65 12.24 412 20366 95348 70812318
Blood triglycerides increased 168.85 12.24 92 20686 19572 70888094
Blood creatine phosphokinase increased 163.84 12.24 139 20639 61124 70846542
Coronary artery disease 141.05 12.24 129 20649 62607 70845059
Acute kidney injury 133.47 12.24 371 20407 474253 70433413
Myocardial infarction 124.19 12.24 198 20580 171447 70736219
Myalgia 120.54 12.24 193 20585 167699 70739967
Drug hypersensitivity 85.52 12.24 217 20561 262242 70645424
Cardiac failure congestive 81.55 12.24 144 20634 135313 70772353
Drug interaction 76.15 12.24 265 20513 381176 70526490
Off label use 72.28 12.24 67 20711 742993 70164673
Myopathy 61.90 12.24 48 20730 18564 70889102
Pancreatitis 60.69 12.24 83 20695 62585 70845081
Drug ineffective 52.15 12.24 125 20653 939627 69968039
Polymyositis 46.53 12.24 21 20757 2980 70904686
Hypertriglyceridaemia 44.90 12.24 33 20745 11778 70895888
Hyperlipidaemia 43.97 12.24 44 20734 23819 70883847
Granulocytopenia 43.33 12.24 31 20747 10616 70897050
Rheumatoid arthritis 42.79 12.24 16 20762 291789 70615877
Myositis 37.40 12.24 35 20743 17454 70890212
Hyperglycaemia 36.63 12.24 67 20711 64605 70843061
Chromaturia 35.51 12.24 39 20739 23489 70884177
Blood glucose increased 34.33 12.24 86 20692 102896 70804770
Blood cholesterol increased 34.18 12.24 65 20713 64539 70843127
International normalised ratio increased 34.13 12.24 74 20704 80652 70827014
Drug intolerance 33.71 12.24 12 20766 225675 70681991
Chronic kidney disease 31.77 12.24 61 20717 60996 70846670
Acute interstitial pneumonitis 31.63 12.24 12 20766 1098 70906568
Blood creatinine increased 29.86 12.24 101 20677 142900 70764766
Angioedema 29.23 12.24 62 20716 66548 70841118
Muscular weakness 28.26 12.24 97 20681 138239 70769427
Drug abuse 27.40 12.24 5 20773 147251 70760415
Pancreatitis acute 27.07 12.24 48 20730 45176 70862490
Treatment failure 26.59 12.24 5 20773 144137 70763529
Haemodialysis 26.58 12.24 29 20749 17337 70890329
Cerebrovascular accident 26.23 12.24 97 20681 143373 70764293
Pyrexia 26.03 12.24 91 20687 606861 70300805
Renal failure 25.98 12.24 117 20661 188953 70718713
Angina unstable 25.13 12.24 27 20751 15866 70891800
Blood glucose decreased 24.90 12.24 33 20745 24126 70883540
Hypoglycaemia 24.62 12.24 72 20706 94292 70813374
General physical health deterioration 24.39 12.24 20 20758 236011 70671655
Joint swelling 24.31 12.24 23 20755 253188 70654478
Lip infection 22.70 12.24 6 20772 167 70907499
Infusion related reaction 22.66 12.24 15 20763 197519 70710147
Lower respiratory tract infection 22.63 12.24 3 20775 111910 70795756
Acute myocardial infarction 22.35 12.24 59 20719 72828 70834838
Treatment noncompliance 21.19 12.24 44 20734 46530 70861136
Coronary artery stenosis 20.59 12.24 21 20757 11623 70896043
Chest pain 20.58 12.24 135 20643 251125 70656541
Thunderclap headache 20.46 12.24 6 20772 246 70907420
Cardiac disorder 20.19 12.24 50 20728 59365 70848301
Erosive duodenitis 20.16 12.24 10 20768 1752 70905914
C-reactive protein increased 20.03 12.24 4 20774 110513 70797153
Renal cyst 19.93 12.24 22 20756 13323 70894343
Arteriosclerosis coronary artery 19.64 12.24 24 20754 16191 70891475
Type 2 diabetes mellitus 19.30 12.24 41 20737 44039 70863627
High density lipoprotein decreased 19.11 12.24 13 20765 4106 70903560
Product use issue 18.89 12.24 15 20763 179922 70727744
Hyperkalaemia 18.59 12.24 71 20707 106520 70801146
Blood urea increased 18.17 12.24 41 20737 45868 70861798
Metabolic acidosis 17.76 12.24 55 20723 74291 70833375
Hypophagia 17.44 12.24 38 20740 41532 70866134
Intervertebral disc displacement 17.12 12.24 6 20772 438 70907228
Condition aggravated 16.43 12.24 67 20711 427568 70480098
Tricuspid valve incompetence 16.34 12.24 23 20755 17794 70889872
Blood creatine phosphokinase MB increased 16.17 12.24 10 20768 2687 70904979
Fanconi syndrome 16.12 12.24 10 20768 2703 70904963
Maternal exposure during pregnancy 15.79 12.24 7 20771 115338 70792328
Coronary artery occlusion 15.41 12.24 20 20758 14325 70893341
Intentional product use issue 15.36 12.24 8 20770 120134 70787532
Myoglobinuria 15.28 12.24 7 20771 1028 70906638
Wound 15.16 12.24 5 20773 98727 70808939
Carotid artery stenosis 14.83 12.24 15 20763 8221 70899445
Ischaemic cardiomyopathy 14.77 12.24 14 20764 7090 70900576
Product complaint 14.64 12.24 18 20760 12213 70895453
Hypercholesterolaemia 14.60 12.24 22 20756 18095 70889571
Iron deficiency anaemia 14.47 12.24 25 20753 23047 70884619
Bursitis 14.30 12.24 27 20751 26646 70881020
Tendon rupture 14.29 12.24 17 20761 11152 70896514
Acute coronary syndrome 14.25 12.24 23 20755 20056 70887610
Alopecia 13.84 12.24 23 20755 198467 70709199
Diabetes mellitus inadequate control 13.50 12.24 24 20754 22621 70885045
Diabetes mellitus 13.48 12.24 49 20729 71775 70835891
Aspartate aminotransferase increased 13.45 12.24 73 20705 126905 70780761
Peripheral swelling 13.40 12.24 31 20747 236532 70671134
Erectile dysfunction 13.17 12.24 18 20760 13544 70894122
Hepatic steatosis 13.16 12.24 30 20748 33783 70873883
Blindness 13.06 12.24 24 20754 23203 70884463
Mitral valve incompetence 13.04 12.24 26 20752 26702 70880964
Asthenia 12.98 12.24 197 20581 457469 70450197
Otitis externa 12.71 12.24 8 20770 2219 70905447
Liver function test abnormal 12.58 12.24 43 20735 61103 70846563
Hyperlactacidaemia 12.51 12.24 11 20767 5061 70902605
Pneumonia haemophilus 12.47 12.24 6 20772 984 70906682
Aortic valve sclerosis 12.41 12.24 7 20771 1590 70906076
Infected bite 12.37 12.24 7 20771 1600 70906066
Myocardial ischaemia 12.36 12.24 24 20754 24176 70883490

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AB04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Fibrates
FDA CS M0199111 PPAR alpha
FDA MoA N0000175375 Peroxisome Proliferator-activated Receptor alpha Agonists
FDA EPC N0000175596 Peroxisome Proliferator Receptor alpha Agonist
CHEBI has role CHEBI:35679 antilipemic drugs
MeSH PA D000963 Antimetabolites
MeSH PA D065687 Cytochrome P-450 CYP2C8 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances

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

DiseaseRelationSNOMED_IDDOID
Hypertriglyceridemia indication 302870006
Primary Prevention of Coronary Heart Disease indication
Hypoalphalipoproteinemia off-label use 190785000
Primary biliary cirrhosis contraindication 31712002 DOID:12236
Disorder of gallbladder contraindication 39621005 DOID:0060262
Acute nephropathy contraindication 58574008
Leukopenia contraindication 84828003 DOID:615
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.13 acidic

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
Peroxisome proliferator-activated receptor alpha Nuclear hormone receptor AGONIST EC50 4.23 IUPHAR CHEMBL
Transthyretin Secreted Kd 7 CHEMBL
Cytochrome P450 2C8 Enzyme Ki 5.74 WOMBAT-PK
Lipoprotein lipase Enzyme WOMBAT-PK
CDGSH iron-sulfur domain-containing protein 1 Unclassified Ki 5.14 CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.52 WOMBAT-PK
Fatty acid-binding protein, liver Unclassified Ki 5.73 CHEMBL

External reference:

IDSource
4018639 VUID
N0000146952 NUI
D00334 KEGG_DRUG
4018639 VANDF
C0017245 UMLSCUI
CHEBI:5296 CHEBI
4TX PDB_CHEM_ID
CHEMBL457 ChEMBL_ID
DB01241 DRUGBANK_ID
D015248 MESH_DESCRIPTOR_UI
3463 PUBCHEM_CID
3439 IUPHAR_LIGAND_ID
3899 INN_ID
Q8X02027X3 UNII
4719 RXNORM
4778 MMSL
523 MMSL
d00245 MMSL
002050 NDDF
35282000 SNOMEDCT_US
387189002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lopid HUMAN PRESCRIPTION DRUG LABEL 1 0071-0737 TABLET, FILM COATED 600 mg ORAL NDA 18 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 0143-9130 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 0143-9707 TABLET, FILM COATED 600 mg ORAL ANDA 18 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 0615-8354 TABLET, FILM COATED 600 mg ORAL ANDA 15 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 0615-8354 TABLET, FILM COATED 600 mg ORAL ANDA 15 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 10544-569 TABLET, FILM COATED 600 mg ORAL ANDA 18 sections
Gemfibrozil Human Prescription Drug Label 1 16571-784 TABLET, FILM COATED 600 mg ORAL ANDA 15 sections
Gemfibrozil Human Prescription Drug Label 1 16714-101 TABLET 600 mg ORAL ANDA 18 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 21695-732 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 24658-260 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 31722-128 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 31722-225 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 33261-146 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 42806-260 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 43063-745 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 43063-745 TABLET 600 mg ORAL ANDA 11 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 43063-921 TABLET 600 mg ORAL ANDA 11 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 43063-921 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 43353-090 TABLET, FILM COATED 600 mg ORAL ANDA 18 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 43353-772 TABLET, FILM COATED 600 mg ORAL ANDA 21 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 43602-452 TABLET 600 mg ORAL ANDA 10 sections
Gemfibrozil Human Prescription Drug Label 1 50090-2450 TABLET, FILM COATED 600 mg ORAL ANDA 15 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 50090-2902 TABLET 600 mg ORAL ANDA 11 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 50090-5808 TABLET 600 mg ORAL ANDA 11 sections
GEMFIBROZIL HUMAN PRESCRIPTION DRUG LABEL 1 50090-5808 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 50268-350 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 51138-588 TABLET, FILM COATED 600 mg ORAL ANDA 18 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 51655-142 TABLET 600 mg ORAL ANDA 9 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 51655-143 TABLET 600 mg ORAL ANDA 11 sections
Gemfibrozil HUMAN PRESCRIPTION DRUG LABEL 1 53002-1068 TABLET 600 mg ORAL ANDA 11 sections