entacapone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
catechol-O-methyltransferase (COMT) inhibitors	1018	130929-57-6

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
1	g	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
Oct. 19, 1999	FDA	ORION PHARMA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyskinesia	429.87	23.50	139	4217	27722	50573046
Hallucination	252.78	23.50	108	4248	46549	50554219
On and off phenomenon	146.58	23.50	32	4324	1380	50599388
Hallucination, visual	143.94	23.50	54	4302	16528	50584240
Dystonia	111.39	23.50	41	4315	11885	50588883
Psychotic disorder	106.46	23.50	47	4309	21765	50579003
Therapeutic response shortened	98.07	23.50	33	4323	7356	50593412
Compulsive shopping	95.70	23.50	20	4336	698	50600070
Sudden onset of sleep	95.62	23.50	19	4337	513	50600255
Impulse-control disorder	91.25	23.50	19	4337	651	50600117
Mutism	87.83	23.50	21	4335	1360	50599408
Delusion	86.53	23.50	33	4323	10536	50590232
Dopamine dysregulation syndrome	74.85	23.50	13	4343	163	50600605
Acute psychosis	68.62	23.50	19	4337	2201	50598567
Muscle rigidity	67.43	23.50	27	4329	9802	50590966
Akinesia	61.28	23.50	16	4340	1483	50599285
Stereotypy	58.85	23.50	12	4344	370	50600398
Freezing phenomenon	57.18	23.50	14	4342	1001	50599767
Camptocormia	55.60	23.50	11	4345	290	50600478
Tremor	52.98	23.50	57	4299	114846	50485922
Dysphagia	49.66	23.50	46	4310	77472	50523296
Orthostatic hypotension	49.22	23.50	31	4325	29450	50571318
Fall	47.62	23.50	95	4261	334837	50265931
Gambling	45.87	23.50	9	4347	227	50600541
Parkinsonian gait	45.77	23.50	10	4346	432	50600336
Gait disturbance	45.34	23.50	60	4296	149945	50450823
Confusional state	43.80	23.50	66	4290	185862	50414906
Impulsive behaviour	42.87	23.50	12	4344	1446	50599322
Agitation	42.82	23.50	36	4320	53348	50547420
Aggression	42.41	23.50	25	4331	21091	50579677
Hyperkinesia	38.39	23.50	11	4345	1441	50599327
Therapeutic product effect variable	36.79	23.50	10	4346	1080	50599688
Pleurothotonus	35.04	23.50	10	4346	1291	50599477
Wrong technique in product usage process	33.72	23.50	32	4324	55478	50545290
Neuroleptic malignant syndrome	32.88	23.50	17	4339	11113	50589655
Gambling disorder	31.36	23.50	9	4347	1185	50599583
Stoma site discharge	30.78	23.50	9	4347	1266	50599502
Eating disorder	30.30	23.50	18	4338	15391	50585377
Stoma site erythema	29.26	23.50	8	4348	883	50599885
Delirium	29.06	23.50	25	4331	38167	50562601
Bradykinesia	27.62	23.50	11	4345	3932	50596836
Rash	27.21	23.50	3	4353	437468	50163300
Parkinson's disease	26.94	23.50	8	4348	1187	50599581
Femoral neck fracture	26.71	23.50	13	4343	7477	50593291
Posture abnormal	26.41	23.50	9	4347	2080	50598688
Abnormal behaviour	26.28	23.50	18	4338	19640	50581128
Balance disorder	25.67	23.50	31	4325	70559	50530209
Parkinsonism hyperpyrexia syndrome	25.30	23.50	5	4351	131	50600637
Ileus	24.83	23.50	15	4341	13214	50587554
Parkinsonism	24.67	23.50	13	4343	8834	50591934
Somnolence	24.40	23.50	46	4310	154939	50445829
Teeth brittle	23.76	23.50	6	4350	487	50600281

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyskinesia	270.13	22.63	116	6301	19945	29548165
Hallucination	269.25	22.63	149	6268	44563	29523547
Hypersexuality	227.99	22.63	54	6363	1302	29566808
Hallucination, visual	209.21	22.63	89	6328	14926	29553184
Gambling disorder	204.82	22.63	51	6366	1524	29566586
On and off phenomenon	189.79	22.63	50	6367	1878	29566232
Muscle rigidity	162.28	22.63	65	6352	9346	29558764
Delusion	116.02	22.63	54	6363	11162	29556948
Freezing phenomenon	115.93	22.63	31	6386	1232	29566878
Dysphagia	98.31	22.63	87	6330	54839	29513271
Parkinson's disease	95.27	22.63	27	6390	1334	29566776
Fall	92.27	22.63	149	6268	177029	29391081
Dopamine dysregulation syndrome	76.13	22.63	17	6400	312	29567798
Neuroleptic malignant syndrome	68.44	22.63	43	6374	16105	29552005
Akinesia	64.95	22.63	22	6395	1968	29566142
Bradykinesia	63.53	22.63	25	6392	3422	29564688
Tremor	58.87	22.63	76	6341	73462	29494648
Cognitive disorder	58.22	22.63	45	6372	23454	29544656
Impulse-control disorder	58.17	22.63	18	6399	1207	29566903
Dementia	54.36	22.63	33	6384	11625	29556485
Confusional state	51.27	22.63	96	6321	127781	29440329
Gait disturbance	48.35	22.63	69	6348	73280	29494830
Aggression	47.61	22.63	48	6369	35493	29532617
Paranoia	43.60	22.63	27	6390	9850	29558260
Agitation	42.55	22.63	54	6363	51250	29516860
Stoma site discharge	41.55	22.63	13	6404	904	29567206
Device dislocation	41.28	22.63	20	6397	4507	29563603
Reduced facial expression	40.50	22.63	12	6405	694	29567416
Therapeutic response shortened	40.21	22.63	20	6397	4771	29563339
Compulsive shopping	37.71	22.63	10	6407	384	29567726
Persecutory delusion	37.60	22.63	15	6402	2126	29565984
Pneumonia aspiration	37.54	22.63	43	6374	36694	29531416
Stereotypy	36.92	22.63	11	6406	648	29567462
Delirium	36.74	22.63	44	6373	39353	29528757
Therapeutic product effect variable	35.95	22.63	14	6403	1863	29566247
Psychotic disorder	35.85	22.63	32	6385	20322	29547788
Posture abnormal	35.45	22.63	14	6403	1933	29566177
Therapeutic product effect decreased	34.44	22.63	37	6380	29414	29538696
Jealous delusion	33.40	22.63	8	6409	202	29567908
Sudden onset of sleep	33.32	22.63	9	6408	371	29567739
Abnormal behaviour	32.36	22.63	32	6385	23095	29545015
Obsessive-compulsive disorder	32.30	22.63	17	6400	4559	29563551
Hyperkinesia	30.88	22.63	12	6405	1587	29566523
Stoma site pain	30.55	22.63	9	6408	510	29567600
Device issue	28.71	22.63	19	6398	7761	29560349
Somnolence	28.61	22.63	63	6354	93892	29474218
Illusion	27.87	22.63	9	6408	693	29567417
Somatic delusion	27.58	22.63	6	6411	97	29568013
Tricuspid valve sclerosis	27.46	22.63	5	6412	30	29568080
Mitral valve sclerosis	26.87	22.63	6	6411	110	29568000
Balance disorder	26.75	22.63	36	6381	36134	29531976
Mobility decreased	26.03	22.63	30	6387	25750	29542360
Abnormal dreams	25.78	22.63	17	6400	6903	29561207
Progressive supranuclear palsy	25.39	22.63	5	6412	48	29568062
Gastric fistula	23.59	22.63	5	6412	71	29568039
Parkinsonism hyperpyrexia syndrome	22.86	22.63	5	6412	83	29568027

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyskinesia	554.59	23.06	204	8207	39184	64451137
Hallucination	375.77	23.06	185	8226	72603	64417718
Hallucination, visual	314.81	23.06	123	8288	27711	64462610
On and off phenomenon	258.22	23.06	61	8350	2458	64487863
Hypersexuality	245.01	23.06	53	8358	1426	64488895
Gambling disorder	205.32	23.06	48	8363	1846	64488475
Muscle rigidity	162.07	23.06	67	8344	17406	64472915
Delusion	146.78	23.06	63	8348	17951	64472370
Impulse-control disorder	129.56	23.06	32	8379	1556	64488765
Therapeutic response shortened	125.72	23.06	48	8363	10122	64480199
Dopamine dysregulation syndrome	124.90	23.06	25	8386	454	64489867
Psychotic disorder	118.55	23.06	67	8344	34511	64455810
Dystonia	115.41	23.06	54	8357	18811	64471510
Freezing phenomenon	110.39	23.06	28	8383	1518	64488803
Compulsive shopping	107.36	23.06	24	8387	753	64489568
Akinesia	104.20	23.06	31	8380	3048	64487273
Dysphagia	95.97	23.06	92	8319	106720	64383601
Parkinson's disease	94.88	23.06	25	8386	1576	64488745
Stereotypy	94.74	23.06	22	8389	820	64489501
Fall	94.50	23.06	183	8228	416643	64073678
Neuroleptic malignant syndrome	92.66	23.06	51	8360	24945	64465376
Sudden onset of sleep	85.36	23.06	19	8392	584	64489737
Confusional state	84.22	23.06	134	8277	261010	64229311
Aggression	79.50	23.06	58	8353	46174	64444147
Agitation	79.13	23.06	76	8335	88291	64402030
Bradykinesia	77.63	23.06	30	8381	6530	64483791
Tremor	75.93	23.06	95	8316	148135	64342186
Mutism	75.49	23.06	22	8389	2012	64488309
Therapeutic product effect variable	70.95	23.06	20	8391	1624	64488697
Gait disturbance	70.70	23.06	99	8312	172056	64318265
Acute psychosis	62.25	23.06	22	8389	3730	64486591
Delirium	60.96	23.06	59	8352	69135	64421186
Hyperkinesia	58.25	23.06	19	8392	2527	64487794
Cognitive disorder	54.30	23.06	50	8361	55037	64435284
Orthostatic hypotension	53.16	23.06	46	8365	46692	64443629
Abnormal behaviour	52.89	23.06	40	8371	33582	64456739
Camptocormia	51.12	23.06	12	8399	469	64489852
Persecutory delusion	49.14	23.06	19	8392	4139	64486182
Parkinsonian gait	49.08	23.06	13	8398	836	64489485
Parkinsonism hyperpyrexia syndrome	48.13	23.06	10	8401	220	64490101
Dementia	47.33	23.06	31	8380	20735	64469586
Gambling	45.85	23.06	10	8401	279	64490042
Posture abnormal	45.42	23.06	17	8394	3389	64486932
Stoma site discharge	44.42	23.06	14	8397	1668	64488653
Progressive supranuclear palsy	42.54	23.06	8	8403	103	64490218
Paranoia	41.19	23.06	26	8385	16326	64473995
Blood creatine phosphokinase increased	40.77	23.06	44	8367	58514	64431807
Reduced facial expression	37.39	23.06	13	8398	2100	64488221
Illusion	37.06	23.06	12	8399	1558	64488763
Torticollis	37.01	23.06	13	8398	2164	64488157
Pneumonia aspiration	36.89	23.06	42	8369	59229	64431092
Jealous delusion	36.83	23.06	8	8403	219	64490102
Arthralgia	36.06	23.06	7	8404	442253	64048068
Device issue	35.74	23.06	27	8384	22621	64467700
Impulsive behaviour	34.45	23.06	13	8398	2650	64487671
Resting tremor	34.17	23.06	11	8400	1403	64488918
Parkinsonism	34.08	23.06	22	8389	14351	64475970
Gastric fistula	33.78	23.06	7	8404	152	64490169
Wrong technique in product usage process	33.77	23.06	42	8369	64932	64425389
Depressed level of consciousness	30.67	23.06	45	8366	81391	64408930
Somnolence	30.61	23.06	76	8335	203569	64286752
Obsessive-compulsive disorder	30.09	23.06	14	8397	4804	64485517
Tricuspid valve sclerosis	30.00	23.06	5	8406	30	64490291
Nightmare	28.72	23.06	23	8388	20970	64469351
Restlessness	27.87	23.06	30	8381	39755	64450566
Femoral neck fracture	27.45	23.06	16	8395	8708	64481613
Deep brain stimulation	27.15	23.06	5	8406	57	64490264
Mania	26.99	23.06	20	8391	16266	64474055
Balance disorder	26.85	23.06	43	8368	83883	64406438
Anxiety	25.72	23.06	71	8340	202578	64287743
Pleurothotonus	25.37	23.06	10	8401	2292	64488029
Obsessive thoughts	24.93	23.06	8	8403	1009	64489312
Abnormal dreams	24.92	23.06	16	8395	10340	64479981
Immobile	24.30	23.06	13	8398	6002	64484319
Stoma site pain	24.09	23.06	8	8403	1125	64489196
Nocturia	23.82	23.06	16	8395	11149	64479172
Hyperpyrexia	23.44	23.06	12	8399	5065	64485256
Stoma site erythema	23.38	23.06	8	8403	1231	64489090
Hyperthermia	23.34	23.06	18	8393	15532	64474789
Headache	23.19	23.06	21	8390	529446	63960875

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Catechol O-methyltransferase	Enzyme	P21964	COMT_HUMAN	INHIBITOR	Ki	9.52	SCIENTIFIC LITERATURE	CHEMBL
G-protein coupled receptor 35	GPCR	Q9HC97	GPR35_HUMAN		EC50	5.25	CHEMBL
Alpha-ketoglutarate-dependent dioxygenase FTO	Unclassified	Q9C0B1	FTO_HUMAN		IC50	5.52	CHEMBL
Catechol O-methyltransferase	Enzyme		COMT_RAT		IC50	7.89	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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