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

Stem definitionDrug idCAS RN
catechol-O-methyltransferase (COMT) inhibitors 1018 130929-57-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • entacapone
  • entacom
  • comtess
Entacapone is a selective and reversible inhibitor of COMT. COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include dopa, catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. The function of COMT is the elimination of biologically active catechols and some other hydroxylated metabolites. When entacapone is given in conjunction with levodopa and an aromatic amino acid decarboxylase inhibitor, such as carbidopa, plasma levels of levodopa are greater and more sustained than after administration of levodopa and an aromatic amino acid decarboxylase inhibitor alone. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain, leading to greater effects on the signs and symptoms of Parkinson's disease.
  • Molecular weight: 305.29
  • Formula: C14H15N3O5
  • CLOGP: 2.66
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 130.38
  • ALOGS: -3.58
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 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) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 87.35 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 42 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.27 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 18, 2011 EMA Teva Pharma B.V.
Oct. 19, 1999 FDA ORION PHARMA

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
Dyskinesia 492.12 25.42 155 4724 31847 63452296
Hallucination 277.45 25.42 117 4762 54700 63429443
On and off phenomenon 203.29 25.42 43 4836 1792 63482351
Hallucination, visual 152.79 25.42 57 4822 19241 63464902
Dystonia 147.78 25.42 51 4828 13768 63470375
Psychotic disorder 120.28 25.42 52 4827 25660 63458483
Therapeutic response shortened 108.47 25.42 39 4840 11849 63472294
Muscle rigidity 105.95 25.42 38 4841 11462 63472681
Sudden onset of sleep 97.03 25.42 19 4860 534 63483609
Compulsive shopping 96.85 25.42 20 4859 739 63483404
Impulse-control disorder 96.05 25.42 20 4859 770 63483373
Mutism 86.73 25.42 21 4858 1609 63482534
Delusion 86.04 25.42 33 4846 11984 63472159
Acute psychosis 82.32 25.42 22 4857 2503 63481640
Freezing phenomenon 81.26 25.42 19 4860 1253 63482890
Dopamine dysregulation syndrome 76.03 25.42 13 4866 167 63483976
Aggression 67.72 25.42 34 4845 23464 63460679
Tremor 64.23 25.42 64 4815 132175 63351968
Akinesia 62.12 25.42 16 4863 1577 63482566
Stoma site discharge 62.07 25.42 16 4863 1582 63482561
Stereotypy 58.46 25.42 12 4867 430 63483713
Camptocormia 56.56 25.42 11 4868 298 63483845
Gait disturbance 55.07 25.42 69 4810 183109 63301034
Fall 51.77 25.42 101 4778 392233 63091910
Parkinsonism hyperpyrexia syndrome 50.78 25.42 9 4870 144 63483999
Dysphagia 50.78 25.42 47 4832 88538 63395605
Orthostatic hypotension 49.07 25.42 32 4847 36128 63448015
Gambling 46.52 25.42 9 4870 237 63483906
Parkinsonian gait 45.29 25.42 10 4869 509 63483634
Impulsive behaviour 43.23 25.42 12 4867 1571 63482572
Agitation 42.82 25.42 36 4843 59721 63424422
Psychomotor hyperactivity 41.58 25.42 19 4860 10644 63473499
Confusional state 41.52 25.42 69 4810 236311 63247832
Therapeutic product effect variable 41.49 25.42 11 4868 1212 63482931
Hyperkinesia 37.88 25.42 11 4868 1693 63482450
Bradykinesia 36.24 25.42 14 4865 5174 63478969
Pleurothotonus 35.81 25.42 10 4869 1339 63482804
Logorrhoea 33.68 25.42 11 4868 2499 63481644
Wrong technique in product usage process 33.64 25.42 32 4847 62308 63421835
Neuroleptic malignant syndrome 33.42 25.42 17 4862 12039 63472104
Speech disorder 32.28 25.42 26 4853 40603 63443540
Stoma site erythema 31.99 25.42 9 4870 1238 63482905
Gambling disorder 31.95 25.42 9 4870 1243 63482900
Balance disorder 30.56 25.42 35 4844 84387 63399756
Rash 29.75 25.42 4 4875 560867 62923276
Stoma site pain 29.17 25.42 8 4871 1002 63483141
Abnormal behaviour 29.15 25.42 19 4860 21407 63462736
Eating disorder 28.69 25.42 18 4861 18998 63465145
Parkinson's disease 27.68 25.42 8 4871 1211 63482932
Delirium 27.37 25.42 26 4853 50515 63433628
Parkinsonism 26.85 25.42 14 4865 10425 63473718
Femoral neck fracture 26.52 25.42 13 4866 8510 63475633
Posture abnormal 26.44 25.42 9 4870 2323 63481820
Stoma site infection 26.11 25.42 7 4872 805 63483338

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
Dyskinesia 311.86 24.20 129 6759 22284 34927759
Hallucination 271.04 24.20 152 6736 51346 34898697
On and off phenomenon 233.79 24.20 61 6827 2436 34947607
Hypersexuality 227.98 24.20 54 6834 1439 34948604
Hallucination, visual 215.97 24.20 93 6795 17698 34932345
Gambling disorder 212.10 24.20 52 6836 1608 34948435
Muscle rigidity 182.33 24.20 71 6817 10447 34939596
Freezing phenomenon 146.05 24.20 38 6850 1498 34948545
Delusion 117.93 24.20 55 6833 12580 34937463
Fall 104.34 24.20 161 6727 202724 34747319
Dysphagia 101.91 24.20 90 6798 62291 34887752
Parkinson's disease 96.63 24.20 27 6861 1397 34948646
Bradykinesia 80.82 24.20 30 6858 3863 34946180
Neuroleptic malignant syndrome 75.71 24.20 46 6842 17888 34932155
Dopamine dysregulation syndrome 72.24 24.20 17 6871 439 34949604
Akinesia 68.98 24.20 23 6865 2161 34947882
Tremor 65.58 24.20 81 6807 82506 34867537
Impulse-control disorder 63.09 24.20 19 6869 1282 34948761
Gait disturbance 57.38 24.20 77 6811 85063 34864980
Cognitive disorder 56.20 24.20 46 6842 28647 34921396
Dementia 52.27 24.20 33 6855 13715 34936328
Confusional state 52.12 24.20 98 6790 144062 34805981
Aggression 49.62 24.20 49 6839 38915 34911128
Stoma site discharge 47.34 24.20 15 6873 1198 34948845
Agitation 43.44 24.20 55 6833 57344 34892699
Paranoia 41.02 24.20 27 6861 12041 34938002
Reduced facial expression 40.56 24.20 13 6875 1078 34948965
Therapeutic product effect variable 40.48 24.20 16 6872 2440 34947603
Device dislocation 39.83 24.20 21 6867 6228 34943815
Delirium 39.54 24.20 46 6842 43945 34906098
Compulsive shopping 38.42 24.20 10 6878 394 34949649
Posture abnormal 38.35 24.20 15 6873 2224 34947819
Hyperkinesia 38.07 24.20 14 6874 1754 34948289
Pneumonia aspiration 37.97 24.20 44 6844 41859 34908184
Psychotic disorder 37.32 24.20 34 6854 24418 34925625
Therapeutic response shortened 36.49 24.20 21 6867 7383 34942660
Stereotypy 36.45 24.20 11 6877 747 34949296
Persecutory delusion 36.29 24.20 15 6873 2565 34947478
Abnormal behaviour 34.78 24.20 33 6855 24936 34925107
Therapeutic product effect decreased 34.05 24.20 38 6850 34705 34915338
Sudden onset of sleep 33.73 24.20 9 6879 391 34949652
Stoma site pain 33.21 24.20 10 6878 674 34949369
Mania 31.65 24.20 21 6867 9490 34940553
Psychomotor hyperactivity 31.42 24.20 21 6867 9601 34940442
Illusion 31.34 24.20 10 6878 817 34949226
Irritability 31.32 24.20 31 6857 24659 34925384
Device issue 31.12 24.20 21 6867 9756 34940287
Jealous delusion 30.99 24.20 8 6880 305 34949738
Abnormal dreams 30.84 24.20 19 6869 7559 34942484
Obsessive-compulsive disorder 30.72 24.20 17 6871 5547 34944496
Mobility decreased 29.60 24.20 33 6855 30095 34919948
Balance disorder 29.24 24.20 38 6850 40616 34909427
Parkinsonism hyperpyrexia syndrome 29.03 24.20 6 6882 83 34949960
Somatic delusion 28.10 24.20 6 6882 98 34949945
Tricuspid valve sclerosis 27.94 24.20 5 6883 30 34950013
Somnolence 27.76 24.20 65 6823 111051 34838992
Sexually inappropriate behaviour 27.09 24.20 8 6880 504 34949539
Stoma site erythema 27.00 24.20 9 6879 844 34949199
Mitral valve sclerosis 26.41 24.20 6 6882 132 34949911
Progressive supranuclear palsy 25.87 24.20 5 6883 48 34949995
Off label use 25.68 24.20 27 6861 419497 34530546
Restlessness 25.18 24.20 28 6860 25454 34924589
Dystonia 24.67 24.20 19 6869 10826 34939217
Anxiety 24.65 24.20 58 6830 99370 34850673
Memory impairment 24.41 24.20 36 6852 43282 34906761
Colitis microscopic 24.38 24.20 11 6877 2326 34947717

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
Dyskinesia 627.23 24.95 223 8860 44550 79690755
Hallucination 403.53 24.95 196 8887 85549 79649756
Hallucination, visual 332.77 24.95 129 8954 32600 79702705
On and off phenomenon 318.94 24.95 74 9009 3166 79732139
Hypersexuality 245.41 24.95 53 9030 1627 79733678
Gambling disorder 213.91 24.95 49 9034 1977 79733328
Muscle rigidity 193.58 24.95 76 9007 19806 79715499
Freezing phenomenon 148.13 24.95 36 9047 1878 79733427
Delusion 147.36 24.95 63 9020 20360 79714945
Dystonia 144.53 24.95 63 9020 21336 79713969
Impulse-control disorder 140.53 24.95 34 9049 1740 79733565
Therapeutic response shortened 134.83 24.95 55 9028 15808 79719497
Psychotic disorder 134.71 24.95 74 9009 41328 79693977
Dopamine dysregulation syndrome 126.37 24.95 25 9058 492 79734813
Akinesia 110.53 24.95 32 9051 3280 79732025
Compulsive shopping 109.42 24.95 24 9059 792 79734513
Aggression 105.36 24.95 68 9015 50890 79684415
Neuroleptic malignant syndrome 102.92 24.95 54 9029 27505 79707800
Dysphagia 101.79 24.95 95 8988 122041 79613264
Fall 101.48 24.95 191 8892 487438 79247867
Parkinson's disease 97.17 24.95 25 9058 1646 79733659
Stereotypy 95.18 24.95 22 9061 923 79734382
Tremor 90.54 24.95 104 8979 169979 79565326
Bradykinesia 89.85 24.95 34 9049 8009 79727296
Sudden onset of sleep 86.68 24.95 19 9064 625 79734680
Gait disturbance 84.75 24.95 111 8972 207395 79527910
Confusional state 82.04 24.95 137 8946 317860 79417445
Agitation 80.05 24.95 76 9007 99639 79635666
Parkinsonism hyperpyrexia syndrome 79.16 24.95 15 9068 233 79735072
Acute psychosis 78.52 24.95 26 9057 4154 79731151
Mutism 75.09 24.95 22 9061 2350 79732955
Therapeutic product effect variable 74.16 24.95 21 9062 1988 79733317
Stoma site discharge 67.79 24.95 20 9063 2189 79733116
Hyperkinesia 63.62 24.95 20 9063 2709 79732596
Delirium 61.33 24.95 61 9022 84566 79650739
Psychomotor hyperactivity 57.21 24.95 31 9052 16818 79718487
Abnormal behaviour 57.15 24.95 41 9042 36380 79698925
Irritability 57.08 24.95 43 9040 41101 79694204
Orthostatic hypotension 55.23 24.95 48 9035 56116 79679189
Camptocormia 52.56 24.95 12 9071 476 79734829
Cognitive disorder 51.76 24.95 51 9032 69875 79665430
Dementia 51.16 24.95 33 9050 24626 79710679
Logorrhoea 50.74 24.95 19 9064 4346 79730959
Parkinsonian gait 49.40 24.95 13 9070 935 79734370
Persecutory delusion 48.57 24.95 19 9064 4890 79730415
Reduced facial expression 47.18 24.95 16 9067 2749 79732556
Gambling 46.83 24.95 10 9073 290 79735015
Device issue 45.96 24.95 32 9051 27076 79708229
Posture abnormal 45.56 24.95 17 9066 3849 79731456
Energy increased 44.49 24.95 16 9067 3266 79732039
Mania 44.33 24.95 27 9056 18233 79717072
Progressive supranuclear palsy 42.48 24.95 8 9075 120 79735185
Illusion 41.59 24.95 13 9070 1728 79733577
Blood creatine phosphokinase increased 41.29 24.95 44 9039 66046 79669259
Behaviour disorder 40.70 24.95 18 9065 6295 79729010
Paranoia 40.30 24.95 26 9057 19406 79715899
Stoma site pain 39.54 24.95 12 9071 1446 79733859
Pneumonia aspiration 39.06 24.95 43 9040 66924 79668381
Arthralgia 38.49 24.95 9 9074 571794 79163511
Hypomania 37.63 24.95 18 9065 7526 79727779
Torticollis 37.56 24.95 13 9070 2374 79732931
Parkinsonism 36.40 24.95 23 9060 16561 79718744
Impulsive behaviour 35.08 24.95 13 9070 2887 79732418
Jealous delusion 34.93 24.95 8 9075 322 79734983
Resting tremor 34.84 24.95 11 9072 1510 79733795
Restlessness 34.56 24.95 34 9049 46458 79688847
Wrong technique in product usage process 34.00 24.95 42 9041 73833 79661472
Gastric fistula 33.33 24.95 7 9076 187 79735118
Balance disorder 32.93 24.95 48 9035 98809 79636496
Somnolence 31.48 24.95 78 9005 238903 79496402
Sexually inappropriate behaviour 30.94 24.95 8 9075 537 79734768
Depressed level of consciousness 30.85 24.95 46 9037 96606 79638699
Stoma site infection 30.74 24.95 10 9073 1510 79733795
Tricuspid valve sclerosis 30.68 24.95 5 9078 30 79735275
Obsessive-compulsive disorder 29.13 24.95 14 9069 5913 79729392
Femoral neck fracture 27.45 24.95 16 9067 9968 79725337
Neurotransmitter level altered 27.31 24.95 4 9079 10 79735295
Nightmare 27.24 24.95 23 9060 25838 79709467
Device dislocation 27.15 24.95 23 9060 25947 79709358
Deep brain stimulation 27.14 24.95 5 9078 66 79735239
Headache 27.04 24.95 21 9062 653751 79081554
Anxiety 26.51 24.95 75 9008 248437 79486868
Pain 26.20 24.95 25 9058 703777 79031528
Pleurothotonus 25.82 24.95 10 9073 2506 79732799
Stoma site erythema 25.48 24.95 9 9074 1744 79733561
Abnormal dreams 25.48 24.95 16 9067 11396 79723909
Nocturia 25.20 24.95 17 9066 13664 79721641
Obsessive thoughts 25.16 24.95 8 9075 1124 79734181

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N04BX02 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Other dopaminergic agents
CHEBI has role CHEBI:35470 central nervous system agents
CHEBI has role CHEBI:48406 catechol O-methyltransferase inhibitors
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:66956 antidyskinetic agent
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D065098 Catechol O-Methyltransferase Inhibitors
MeSH PA D002491 Central Nervous System Agents
MeSH PA D004791 Enzyme Inhibitors
FDA MoA N0000175756 Catechol O-Methyltransferase Inhibitors
FDA EPC N0000175757 Catechol-O-Methyltransferase Inhibitor

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

DiseaseRelationSNOMED_IDDOID
Parkinson's disease indication 49049000 DOID:14330
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Dyskinesia contraindication 9748009
Peptic ulcer contraindication 13200003 DOID:750
Disorder of lung contraindication 19829001 DOID:850
Myocardial infarction contraindication 22298006 DOID:5844
Orthostatic hypotension contraindication 28651003
Obstruction of bile duct contraindication 30144000
Depressive disorder contraindication 35489007
Conduction disorder of the heart contraindication 44808001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Diarrhea contraindication 62315008
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Open-angle glaucoma contraindication 84494001 DOID:1067
Kidney disease contraindication 90708001 DOID:557
Acute disease of cardiovascular system contraindication 128487001
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Retention of urine contraindication 267064002
Psychoneurotic personality disorder contraindication 268634009
Malignant melanoma contraindication 372244006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808




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 4.41 acidic
pKa2 13.34 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
Catechol O-methyltransferase Enzyme INHIBITOR Ki 9.52 SCIENTIFIC LITERATURE CHEMBL
G-protein coupled receptor 35 GPCR EC50 5.25 CHEMBL
Alpha-ketoglutarate-dependent dioxygenase FTO Unclassified IC50 5.52 CHEMBL
Mitochondrial pyruvate carrier 2 Transporter INHIBITOR IC50 6.22 IUPHAR
Catechol O-methyltransferase Enzyme IC50 7.89 CHEMBL

External reference:

IDSource
4021181 VUID
N0000148629 NUI
D00781 KEGG_DRUG
4021181 VANDF
C0165921 UMLSCUI
CHEBI:4798 CHEBI
PD9 PDB_CHEM_ID
CHEMBL953 ChEMBL_ID
DB00494 DRUGBANK_ID
C071192 MESH_SUPPLEMENTAL_RECORD_UI
5281081 PUBCHEM_CID
6647 IUPHAR_LIGAND_ID
6812 INN_ID
4975G9NM6T UNII
227109 RXNORM
66346 MMSL
8477 MMSL
d04460 MMSL
007684 NDDF
116116003 SNOMEDCT_US
387018000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Comtan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0327 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0407 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0408 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0409 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0527 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0544 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Stalevo HUMAN PRESCRIPTION DRUG LABEL 3 0078-0545 TABLET, FILM COATED 200 mg ORAL NDA 25 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8300 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8301 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8302 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8303 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8304 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Carbidopa, Levodopa and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0378-8305 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 24 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0378-9080 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 21 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0527-1830 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8298 TABLET 200 mg ORAL ANDA 19 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5578 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 13 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5613 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5625 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5637 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5641 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5654 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Carbidopa, Levodopa, and Entacapone HUMAN PRESCRIPTION DRUG LABEL 3 0781-5669 TABLET, FILM COATED 200 mg ORAL NDA authorized generic 26 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6822 TABLET, FILM COATED 200 mg ORAL ANDA 20 sections
Entacapone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6822 TABLET, FILM COATED 200 mg ORAL ANDA 20 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-689 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-690 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-691 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-692 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-693 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections