entacapone 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: 1.76
  • 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 ┬ÁM/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
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 564.42 22.81 199 7254 31634 53309979
Hallucination 394.69 22.81 178 7275 53660 53287953
On and off phenomenon 242.42 22.81 59 7394 2519 53339094
Hallucination, visual 192.79 22.81 79 7374 18753 53322860
Muscle rigidity 151.52 22.81 57 7396 10784 53330829
Therapeutic response shortened 132.01 22.81 46 7407 6993 53334620
Freezing phenomenon 120.92 22.81 31 7422 1636 53339977
Delusion 118.17 22.81 49 7404 11960 53329653
Psychotic disorder 112.87 22.81 59 7394 24326 53317287
Dysphagia 111.31 22.81 93 7360 84304 53257309
Akinesia 97.13 22.81 27 7426 1944 53339669
Sudden onset of sleep 92.71 22.81 21 7432 652 53340961
Dopamine dysregulation syndrome 91.25 22.81 18 7435 281 53341332
Tremor 90.20 22.81 99 7354 125637 53215976
Dystonia 88.65 22.81 41 7412 12980 53328633
Stoma site discharge 88.00 22.81 26 7427 2328 53339285
Fall 87.60 22.81 169 7284 358271 52983342
Wrong technique in product usage process 87.17 22.81 70 7383 59962 53281651
Impulse-control disorder 83.27 22.81 20 7433 805 53340808
Bradykinesia 79.89 22.81 28 7425 4325 53337288
Confusional state 78.74 22.81 115 7338 194106 53147507
Compulsive shopping 68.01 22.81 17 7436 809 53340804
Gait disturbance 62.79 22.81 93 7360 158749 53182864
Delirium 61.58 22.81 49 7404 41380 53300233
Ileus 60.22 22.81 33 7420 14922 53326691
Stoma site erythema 57.64 22.81 17 7436 1512 53340101
Orthostatic hypotension 57.09 22.81 41 7412 29712 53311901
Dementia 56.73 22.81 33 7420 16717 53324896
Stereotypy 51.31 22.81 12 7441 430 53341183
Stoma site pain 51.00 22.81 15 7438 1321 53340292
Acute psychosis 49.70 22.81 17 7436 2441 53339172
Speech disorder 49.15 22.81 42 7411 39139 53302474
Parkinson's disease 48.98 22.81 15 7438 1516 53340097
Hyperkinesia 48.59 22.81 16 7437 2044 53339569
Camptocormia 48.54 22.81 11 7442 342 53341271
Psychomotor hyperactivity 48.32 22.81 25 7428 10071 53331542
Parkinsonian crisis 43.87 22.81 7 7446 28 53341585
Parkinsonism 39.38 22.81 21 7432 8992 53332621
Restlessness 39.13 22.81 32 7421 28055 53313558
Stoma site infection 37.55 22.81 11 7442 955 53340658
Rash 36.11 22.81 9 7444 446182 52895431
Vascular encephalopathy 35.65 22.81 9 7444 446 53341167
Femoral neck fracture 35.14 22.81 19 7434 8364 53333249
Reduced facial expression 34.95 22.81 12 7441 1742 53339871
Neuroleptic malignant syndrome 33.73 22.81 21 7432 12012 53329601
Pleurothotonus 33.69 22.81 11 7442 1368 53340245
Agitation 33.30 22.81 41 7412 58585 53283028
Rheumatoid arthritis 33.00 22.81 3 7450 314528 53027085
Abnormal behaviour 32.77 22.81 26 7427 21840 53319773
Somnolence 31.29 22.81 71 7382 167663 53173950
Subileus 31.21 22.81 13 7440 3203 53338410
Choking 30.68 22.81 18 7435 9258 53332355
Therapeutic product effect variable 30.62 22.81 10 7443 1245 53340368
Gambling disorder 29.55 22.81 10 7443 1390 53340223
Balance disorder 29.05 22.81 43 7410 73164 53268449
Nocturia 28.38 22.81 16 7437 7634 53333979
Chromaturia 28.36 22.81 21 7432 15929 53325684
Depressed level of consciousness 27.63 22.81 36 7417 54392 53287221
Nightmare 26.37 22.81 21 7432 17730 53323883
Stoma site extravasation 26.35 22.81 7 7446 424 53341189
Arthralgia 25.44 22.81 15 7438 439768 52901845
Hypokinesia 25.09 22.81 18 7435 13009 53328604
Posture abnormal 24.53 22.81 10 7443 2333 53339280
Pneumonia aspiration 24.51 22.81 27 7426 34274 53307339
Stoma site hypergranulation 24.39 22.81 7 7446 565 53341048
Abnormal dreams 23.57 22.81 16 7437 10585 53331028
Movement disorder 23.36 22.81 20 7433 18661 53322952
Dropped head syndrome 23.11 22.81 5 7448 125 53341488

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
Hallucination 478.33 19.67 269 10897 52350 32450010
Dyskinesia 418.94 19.67 190 10976 23413 32478947
On and off phenomenon 257.30 19.67 80 11086 3421 32498939
Hypersexuality 253.25 19.67 67 11099 1590 32500770
Hallucination, visual 251.16 19.67 121 11045 17038 32485322
Gambling disorder 217.62 19.67 61 11105 1808 32500552
Muscle rigidity 207.56 19.67 93 11073 11093 32491267
Freezing phenomenon 199.16 19.67 60 11106 2303 32500057
Dysphagia 179.95 19.67 157 11009 61319 32441041
Fall 150.67 19.67 253 10913 195948 32306412
Parkinson's disease 150.52 19.67 45 11121 1681 32500679
Delusion 137.89 19.67 74 11092 13034 32489326
Confusional state 128.04 19.67 198 10968 142917 32359443
Impulse-control disorder 124.81 19.67 38 11128 1511 32500849
Bradykinesia 124.33 19.67 49 11117 4237 32498123
Dopamine dysregulation syndrome 117.69 19.67 29 11137 512 32501848
Akinesia 112.55 19.67 40 11126 2593 32499767
Aggression 98.18 19.67 92 11074 39297 32463063
Device dislocation 83.34 19.67 41 11125 6022 32496338
Cognitive disorder 81.43 19.67 69 11097 25825 32476535
Tremor 77.51 19.67 116 11050 81161 32421199
Gait disturbance 77.02 19.67 115 11051 80293 32422067
Psychotic disorder 75.80 19.67 63 11103 22957 32479403
Agitation 73.01 19.67 94 11072 57142 32445218
Stoma site discharge 70.16 19.67 26 11140 1899 32500461
Hyperkinesia 69.38 19.67 27 11139 2255 32500105
Dementia 69.28 19.67 48 11118 13338 32489022
Neuroleptic malignant syndrome 68.50 19.67 53 11113 17442 32484918
Jealous delusion 66.22 19.67 16 11150 259 32502101
Stereotypy 59.69 19.67 18 11148 692 32501668
Abnormal behaviour 56.84 19.67 57 11109 26409 32475951
Reduced facial expression 55.37 19.67 18 11148 888 32501472
Stoma site erythema 55.06 19.67 20 11146 1380 32500980
Embedded device 54.72 19.67 17 11149 723 32501637
Delirium 54.05 19.67 71 11095 43975 32458385
Compulsive shopping 53.31 19.67 15 11151 450 32501910
Pneumonia aspiration 51.52 19.67 67 11099 41089 32461271
Device occlusion 48.73 19.67 30 11136 6828 32495532
Wrong technique in product usage process 48.51 19.67 60 11106 34999 32467361
Paranoia 47.32 19.67 35 11131 10764 32491596
Posture abnormal 46.36 19.67 20 11146 2173 32500187
Psychomotor hyperactivity 45.80 19.67 32 11134 9007 32493353
Mobility decreased 43.18 19.67 51 11115 28358 32474002
Choking 42.94 19.67 25 11141 5141 32497219
Stoma site pain 42.77 19.67 15 11151 934 32501426
Abnormal dreams 42.65 19.67 30 11136 8534 32493826
Device issue 41.57 19.67 30 11136 8882 32493478
Dystonia 41.17 19.67 32 11134 10591 32491769
Therapeutic response shortened 39.65 19.67 23 11143 4697 32497663
Stoma site infection 39.02 19.67 15 11151 1212 32501148
Somnolence 38.99 19.67 100 11066 103697 32398663
Libido increased 36.43 19.67 13 11153 852 32501508
Anticholinergic syndrome 35.93 19.67 13 11153 887 32501473
Acute kidney injury 35.89 19.67 29 11137 293439 32208921
Motor dysfunction 35.27 19.67 24 11142 6472 32495888
Sudden onset of sleep 35.09 19.67 11 11155 482 32501878
Oesophageal achalasia 33.47 19.67 10 11156 372 32501988
Illusion 33.20 19.67 12 11154 816 32501544
Balance disorder 32.90 19.67 53 11113 39406 32462954
Persecutory delusion 32.68 19.67 16 11150 2323 32500037
Intentional medical device removal by patient 32.37 19.67 10 11156 417 32501943
Therapeutic product effect decreased 32.00 19.67 46 11120 30971 32471389
Parkinsonism hyperpyrexia syndrome 31.90 19.67 8 11158 152 32502208
Hypersomnia 31.81 19.67 29 11137 11932 32490428
Nightmare 31.32 19.67 30 11136 13136 32489224
Therapeutic product effect variable 31.28 19.67 15 11151 2081 32500279
Sleep talking 30.65 19.67 10 11156 499 32501861
Memory impairment 30.57 19.67 52 11114 40427 32461933
Musculoskeletal stiffness 30.39 19.67 51 11115 39213 32463147
Depressed mood 29.72 19.67 34 11132 18266 32484094
Immobile 29.04 19.67 15 11151 2439 32499921
Soft tissue mass 28.78 19.67 9 11157 391 32501969
Device kink 28.17 19.67 10 11156 645 32501715
Febrile neutropenia 27.81 19.67 4 11162 119562 32382798
Hypokinesia 27.64 19.67 23 11143 8382 32493978
Stoma site haemorrhage 27.09 19.67 11 11155 1027 32501333
Orthostatic hypotension 26.40 19.67 38 11128 25612 32476748
Obsessive-compulsive disorder 26.24 19.67 18 11148 4916 32497444
Movement disorder 26.06 19.67 25 11141 10966 32491394
Renal failure 26.05 19.67 7 11159 134471 32367889
Restlessness 25.81 19.67 37 11129 24844 32477516
Thunderclap headache 25.32 19.67 6 11160 89 32502271
Parkinsonism 24.78 19.67 21 11145 7848 32494512
Hyperthermia 24.68 19.67 24 11142 10704 32491656
Gambling 24.41 19.67 7 11159 225 32502135
Anxiety 23.98 19.67 80 11086 95925 32406435
Tricuspid valve sclerosis 23.91 19.67 5 11161 40 32502320
Depressive symptom 23.85 19.67 12 11154 1846 32500514
Somatic delusion 23.23 19.67 6 11160 129 32502231
Neutropenia 23.04 19.67 10 11156 142165 32360195
Underdose 22.44 19.67 25 11141 13044 32489316
Mitral valve sclerosis 22.22 19.67 6 11160 154 32502206
Platelet count decreased 22.12 19.67 6 11160 114585 32387775
Impulsive behaviour 22 19.67 12 11154 2177 32500183
Nasal discomfort 21.77 19.67 10 11156 1259 32501101
Product use complaint 21.73 19.67 10 11156 1264 32501096
Progressive supranuclear palsy 21.71 19.67 5 11161 65 32502295
Dyspnoea 21.55 19.67 59 11107 361986 32140374
Dysstasia 21.51 19.67 23 11143 11463 32490897
Pancytopenia 21.33 19.67 3 11163 91232 32411128
Toxicity to various agents 21.22 19.67 18 11148 178023 32324337
Gait inability 21.07 19.67 30 11136 20017 32482343
Pelvic fracture 21.02 19.67 12 11154 2376 32499984
Pruritus 20.93 19.67 9 11157 128693 32373667
Gastric fistula 20.69 19.67 5 11161 81 32502279
Off label use 20.48 19.67 47 11119 306273 32196087
Feeling abnormal 20.40 19.67 56 11110 60367 32441993
Autonomic nervous system imbalance 20.25 19.67 12 11154 2548 32499812
Device breakage 20.18 19.67 11 11155 1993 32500367
Saliva discolouration 19.99 19.67 4 11162 25 32502335
Gastrointestinal haemorrhage 19.98 19.67 3 11163 86879 32415481

Pharmacologic Action:

SourceCodeDescription
ATC N04BX02 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Other dopaminergic agents
CHEBI has role CHEBI:35470 CNS agent
CHEBI has role CHEBI:48406 catechol O-methyltransferase inhibitors
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:66956 antidyskinetic drugs
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 (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

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
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
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
CARBIDOPA, LEVODOPA AND ENTACAPONE Human Prescription Drug Label 3 16571-694 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections