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

Stem definition	Drug id	CAS RN
antivirals carbocyclic nucleosides	1019	142217-69-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: entecavir monohydrate anhydrous entecavir BMS-200475-01 entecavir baraclude entecavir hydrate	Entecavir, a guanosine nucleoside analogue with activity against HBV reverse transcriptase, is efficiently phosphorylated to the active triphosphate form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits all three activities of the HBV reverse transcriptase: (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. Entecavir triphosphate is a weak inhibitor of cellular DNA polymerases alpha, beta, and delta and mitochondrial DNA polymerase gamma with Ki values ranging from 18 to > 160 microM. Molecular weight: 277.28 Formula: C12H15N5O3 CLOGP: -1.78 LIPINSKI: 0 HAC: 8 HDO: 4 TPSA: 125.76 ALOGS: -1.63 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

entecavir monohydrate
anhydrous entecavir
BMS-200475-01
entecavir
baraclude
entecavir hydrate

Entecavir, a guanosine nucleoside analogue with activity against HBV reverse transcriptase, is efficiently phosphorylated to the active triphosphate form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits all three activities of the HBV reverse transcriptase: (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. Entecavir triphosphate is a weak inhibitor of cellular DNA polymerases alpha, beta, and delta and mitochondrial DNA polymerase gamma with Ki values ranging from 18 to > 160 microM.

Molecular weight: 277.28
Formula: C12H15N5O3
CLOGP: -1.78
LIPINSKI: 0
HAC: 8
HDO: 4
TPSA: 125.76
ALOGS: -1.63
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	2.40 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	70 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.05 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	1 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
June 26, 2006	EMA	BRISTOL-MYERS SQUIBB PHARMA EEIG
March 29, 2005	FDA	BRISTOL MYERS SQUIBB

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
Drug resistance	142.38	20.59	57	4897	22876	63461192
Hepatitis B reactivation	134.11	20.59	34	4920	3103	63480965
Hepatitis B DNA increased	103.36	20.59	18	4936	255	63483813
Viral load increased	100.63	20.59	23	4931	1351	63482717
Hepatitis B	99.63	20.59	28	4926	3784	63480284
Hepatocellular carcinoma	85.05	20.59	22	4932	2172	63481896
Exposure via body fluid	77.00	20.59	16	4938	600	63483468
Hypophosphataemia	62.65	20.59	26	4928	11400	63472668
Abortion induced	55.12	20.59	23	4931	10219	63473849
Viral mutation identified	50.51	20.59	14	4940	1796	63482272
Hepatic cancer	49.38	20.59	17	4937	4470	63479598
Hepatic function abnormal	43.09	20.59	30	4924	37112	63446956
Liver transplant	42.92	20.59	13	4941	2278	63481790
Pulmonary microemboli	42.30	20.59	5	4949	0	63484068
Osteomalacia	41.54	20.59	10	4944	735	63483333
Pathogen resistance	40	20.59	16	4938	6382	63477686
Hepatic failure	39.50	20.59	28	4926	35628	63448440
Fanconi syndrome acquired	38.27	20.59	10	4944	1026	63483042
Febrile neutropenia	35.60	20.59	45	4909	118404	63365664
Neutropenia	35.45	20.59	55	4899	174950	63309118
Abortion spontaneous	32.54	20.59	28	4926	47167	63436901
Hepatic encephalopathy	31.30	20.59	16	4938	11266	63472802
Renal impairment	30.48	20.59	36	4918	88319	63395749
Neutrophil count decreased	30.14	20.59	29	4925	56377	63427691
Maternal exposure during pregnancy	28.72	20.59	57	4897	220005	63264063
Platelet count decreased	28.55	20.59	40	4914	116082	63367986
Pregnancy on contraceptive	27.74	20.59	8	4946	1184	63482884
Cryoglobulinaemia	24.59	20.59	6	4948	467	63483601
Leukopenia	24.22	20.59	30	4924	77260	63406808
Acute hepatic failure	24.09	20.59	16	4938	18311	63465757
Cardiac failure	23.86	20.59	32	4922	89110	63394958
Urinary tract stoma complication	23.82	20.59	4	4950	45	63484023
Systemic infection	23.52	20.59	10	4944	4650	63479418
Thrombocytopenia	23.23	20.59	42	4912	151115	63332953
Hepatitis C	22.33	20.59	10	4944	5264	63478804
Fanconi syndrome	22.27	20.59	7	4947	1385	63482683
Viral uveitis	22.22	20.59	4	4950	69	63483999
Gastroenteritis staphylococcal	21.86	20.59	4	4950	76	63483992

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
Drug resistance	342.43	16.54	162	10083	25765	34920921
Hepatocellular carcinoma	307.44	16.54	106	10139	7403	34939283
Viral mutation identified	274.23	16.54	78	10167	2876	34943810
Hepatic cancer	245.32	16.54	92	10153	8183	34938503
Hepatitis B DNA increased	190.76	16.54	42	10203	523	34946163
Hepatic failure	187.47	16.54	120	10125	34411	34912275
Genotype drug resistance test	179.81	16.54	29	10216	45	34946641
Hepatitis B reactivation	171.19	16.54	58	10187	3833	34942853
Pathogen resistance	139.72	16.54	64	10181	9418	34937268
Hepatitis B	129.54	16.54	53	10192	5930	34940756
Viral load increased	120.38	16.54	40	10205	2487	34944199
Hepatic encephalopathy	115.95	16.54	65	10180	14620	34932066
Osteomalacia	111.77	16.54	30	10215	887	34945799
Ascites	109.19	16.54	98	10147	46473	34900213
Fanconi syndrome acquired	108.93	16.54	35	10210	1956	34944730
Multiple-drug resistance	98.59	16.54	42	10203	5197	34941489
Hepatic cirrhosis	93.43	16.54	60	10185	17254	34929432
Blood HIV RNA decreased	85.63	16.54	12	10233	0	34946686
Hypophosphataemia	84.85	16.54	48	10197	10978	34935708
Hepatic function abnormal	74.96	16.54	78	10167	44285	34902401
Genotype drug resistance test positive	70.38	16.54	22	10223	1123	34945563
Hepatitis B surface antigen positive	61.82	16.54	13	10232	128	34946558
Blood phosphorus decreased	58.19	16.54	25	10220	3156	34943530
Portal vein thrombosis	47.85	16.54	23	10222	3765	34942921
Osteoporosis	47.29	16.54	35	10210	12633	34934053
Viral infection	45.07	16.54	39	10206	17584	34929102
Fanconi syndrome	43.33	16.54	17	10228	1703	34944983
Blood bilirubin increased	42.15	16.54	54	10191	38242	34908444
Alanine aminotransferase increased	38.80	16.54	78	10167	80737	34865949
Palmar-plantar erythrodysaesthesia syndrome	38.62	16.54	35	10210	16760	34929926
Renal impairment	38.17	16.54	85	10160	94428	34852258
Mycoplasma infection	34.32	16.54	10	10235	401	34946285
Autoimmune haemolytic anaemia	30.39	16.54	18	10227	4478	34942208
Renal tubular injury	29.36	16.54	11	10234	972	34945714
Portal vein occlusion	28.01	16.54	6	10239	65	34946621
Oesophageal varices haemorrhage	27.77	16.54	15	10230	3131	34943555
Proteinuria	26.59	16.54	30	10215	18612	34928074
Hypocalciuria	26.31	16.54	4	10241	3	34946683
Asymptomatic viral hepatitis	26.25	16.54	5	10240	28	34946658
Parotid gland haemorrhage	25.96	16.54	5	10240	30	34946656
Malignant anorectal neoplasm	25.29	16.54	5	10240	35	34946651
Retinal toxicity	25.15	16.54	8	10237	432	34946254
Liver transplant	24.96	16.54	13	10232	2521	34944165
Optic disc hyperaemia	24.88	16.54	4	10241	6	34946680
Retinal depigmentation	24.18	16.54	5	10240	45	34946641
Aspartate aminotransferase increased	24.08	16.54	58	10187	67725	34878961
Retinopathy hypertensive	24.04	16.54	7	10238	280	34946406
Hepatitis B e antigen positive	23.80	16.54	5	10240	49	34946637
Jaundice	23.30	16.54	37	10208	31845	34914841
Renal tubular acidosis	23.14	16.54	12	10233	2307	34944379
Hepatitis B virus test positive	23.14	16.54	7	10238	320	34946366
Foetal hypokinesia	22.03	16.54	7	10238	377	34946309
Foetal heart rate abnormal	22.01	16.54	6	10239	188	34946498
Mitochondrial myopathy	21.69	16.54	6	10239	199	34946487
Renal glycosuria	21.55	16.54	4	10241	19	34946667
Blood uric acid	21.41	16.54	3	10242	0	34946686
Liver transplant rejection	21.24	16.54	11	10234	2108	34944578
Varices oesophageal	20.21	16.54	13	10232	3742	34942944
Platelet count decreased	19.49	16.54	78	10167	119639	34827047
Alkalosis hypokalaemic	19.33	16.54	3	10242	3	34946683
Antiviral drug level below therapeutic	19.33	16.54	3	10242	3	34946683
Drug abuse	19.27	16.54	3	10242	99093	34847593
Completed suicide	19.02	16.54	3	10242	98165	34848521
Hepatorenal syndrome	18.88	16.54	11	10234	2655	34944031
Blood creatine phosphokinase increased	18.82	16.54	41	10204	44816	34901870
HIV associated nephropathy	18.81	16.54	6	10239	327	34946359
Dyspnoea	18.68	16.54	53	10192	376729	34569957
Ileal ulcer	18.63	16.54	7	10238	623	34946063
Schistosomiasis	18.37	16.54	4	10241	47	34946639
Hepatitis B antigen positive	18.11	16.54	3	10242	6	34946680
Laryngeal erythema	18.11	16.54	3	10242	6	34946680
Transaminases increased	18.06	16.54	30	10215	26793	34919893
Venoocclusive liver disease	17.14	16.54	16	10229	7950	34938736
Amylase increased	16.88	16.54	14	10231	5954	34940732
Malaria	16.75	16.54	5	10240	218	34946468
Hepatectomy	16.73	16.54	4	10241	73	34946613
Lipase increased	16.68	16.54	17	10228	9399	34937287

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
Hepatocellular carcinoma	371.64	16.25	112	13314	8909	79722053
Viral mutation identified	340.00	16.25	87	13339	3771	79727191
Hepatic cancer	321.64	16.25	104	13322	10425	79720537
Drug resistance	297.06	16.25	144	13282	42069	79688893
Hepatitis B reactivation	291.54	16.25	85	13341	6023	79724939
Hepatitis B DNA increased	245.14	16.25	50	13376	765	79730197
Hepatic failure	230.96	16.25	138	13288	61074	79669888
Pathogen resistance	181.87	16.25	74	13352	14268	79716694
Viral load increased	162.91	16.25	46	13380	2902	79728060
Hepatic encephalopathy	153.69	16.25	77	13349	24089	79706873
Hepatitis B	140.99	16.25	53	13373	8279	79722683
Fanconi syndrome acquired	139.69	16.25	40	13386	2654	79728308
Hypophosphataemia	134.17	16.25	66	13360	19847	79711115
Osteomalacia	133.43	16.25	34	13392	1446	79729516
Hepatic function abnormal	124.19	16.25	101	13325	73006	79657956
Ascites	119.19	16.25	100	13326	75462	79655500
Multiple-drug resistance	103.34	16.25	43	13383	8765	79722197
Genotype drug resistance test positive	98.30	16.25	26	13400	1282	79729680
Hepatic cirrhosis	85.39	16.25	60	13366	34846	79696116
Renal impairment	83.33	16.25	117	13309	157666	79573296
Blood HIV RNA decreased	76.90	16.25	10	13416	0	79730962
Blood bilirubin increased	66.21	16.25	68	13358	66164	79664798
Portal vein thrombosis	63.51	16.25	27	13399	5800	79725162
Hepatitis B surface antigen positive	59.88	16.25	12	13414	167	79730795
Liver transplant	56.66	16.25	23	13403	4400	79726562
Fanconi syndrome	51.35	16.25	19	13407	2837	79728125
Platelet count decreased	50.22	16.25	105	13321	194559	79536403
Oesophageal varices haemorrhage	47.40	16.25	20	13406	4216	79726746
Alanine aminotransferase increased	47.06	16.25	92	13334	162478	79568484
Proteinuria	45.09	16.25	40	13386	32462	79698500
Blood phosphorus decreased	44.60	16.25	22	13404	6646	79724316
Palmar-plantar erythrodysaesthesia syndrome	44.42	16.25	40	13386	33094	79697868
Jaundice	43.18	16.25	49	13377	53300	79677662
Joint swelling	32.30	16.25	5	13421	288641	79442321
Liver transplant rejection	31.95	16.25	14	13412	3234	79727728
Blood creatine phosphokinase increased	31.89	16.25	47	13379	66043	79664919
Pulmonary microemboli	31.78	16.25	5	13421	14	79730948
Acute hepatic failure	30.23	16.25	31	13395	30082	79700880
Abortion induced	29.32	16.25	17	13409	7092	79723870
Blood creatinine increased	29.29	16.25	74	13352	154983	79575979
Febrile neutropenia	28.85	16.25	95	13331	230904	79500058
Parotid gland haemorrhage	28.58	16.25	5	13421	31	79730931
Thrombocytopenia	27.03	16.25	102	13324	265157	79465805
Antiviral drug level below therapeutic	26.94	16.25	5	13421	45	79730917
Renal tubular injury	26.92	16.25	10	13416	1509	79729453
Osteoporosis	26.86	16.25	39	13387	54073	79676889
Autoimmune haemolytic anaemia	26.73	16.25	17	13409	8363	79722599
Transaminases increased	26.72	16.25	38	13388	51705	79679257
Portal vein occlusion	26.12	16.25	5	13421	54	79730908
Mycoplasma infection	24.92	16.25	8	13418	781	79730181
Malignant anorectal neoplasm	24.73	16.25	5	13421	73	79730889
Pain	24.67	16.25	51	13375	703751	79027211
Optic disc hyperaemia	24.53	16.25	4	13422	15	79730947
Anxiety	24.24	16.25	6	13420	248506	79482456
Retinopathy hypertensive	23.94	16.25	7	13419	500	79730462
Pregnancy on contraceptive	23.76	16.25	8	13418	907	79730055
Liver abscess	23.71	16.25	14	13412	6040	79724922
Hypoalbuminaemia	23.35	16.25	23	13403	21274	79709688
Blood uric acid	23.07	16.25	3	13423	0	79730962
Hypocalciuria	22.98	16.25	4	13422	24	79730938
Death	22.68	16.25	168	13258	566346	79164616
Drug hypersensitivity	22.66	16.25	11	13415	298905	79432057
Neutropenia	22.50	16.25	102	13324	287608	79443354
Product substitution issue	22.44	16.25	22	13404	20234	79710728
HIV associated nephropathy	22.02	16.25	6	13420	331	79730631
Renal glycosuria	21.87	16.25	4	13422	33	79730929
Lactic acidosis	21.78	16.25	41	13385	70318	79660644
Interstitial lung disease	21.53	16.25	54	13372	112546	79618416
Renal tubular acidosis	21.45	16.25	11	13415	3603	79727359
Nasopharyngitis	21.38	16.25	8	13418	253873	79477089
Pyrexia	21.09	16.25	190	13236	678519	79052443
Aspartate aminotransferase increased	20.99	16.25	61	13365	138580	79592382
Retinal toxicity	20.37	16.25	8	13418	1403	79729559
Hepatectomy	20.01	16.25	5	13421	196	79730766
Schistosomiasis	19.87	16.25	4	13422	57	79730905
Hepatorenal syndrome	19.78	16.25	11	13415	4238	79726724
Liver disorder	19.74	16.25	40	13386	72377	79658585
Hepatitis B virus test positive	19.70	16.25	6	13420	493	79730469
Therapeutic embolisation	19.65	16.25	6	13420	497	79730465
Leukopenia	19.34	16.25	53	13373	116460	79614502
Toxicity to various agents	18.94	16.25	26	13400	421514	79309448
White blood cell count decreased	18.83	16.25	72	13354	188216	79542746
Varices oesophageal	18.73	16.25	12	13414	5979	79724983
Urinary tract stoma complication	18.55	16.25	4	13422	81	79730881
Ileal ulcer	18.43	16.25	7	13419	1123	79729839
Drug intolerance	18.14	16.25	11	13415	264108	79466854
Mitochondrial myopathy	18.08	16.25	5	13421	292	79730670
Amylase increased	17.99	16.25	15	13411	11194	79719768
Swelling	17.96	16.25	7	13419	216704	79514258
Therapeutic product effect decreased	17.96	16.25	3	13423	163860	79567102
Bone pain	17.90	16.25	33	13393	55709	79675253
Renal tubular disorder	17.86	16.25	12	13414	6474	79724488
Urine protein/creatinine ratio increased	17.83	16.25	7	13419	1227	79729735
Haemorrhagic cholecystitis	17.78	16.25	4	13422	99	79730863
Viral uveitis	17.74	16.25	4	13422	100	79730862
Retinal depigmentation	17.63	16.25	5	13421	320	79730642
Venoocclusive liver disease	17.35	16.25	15	13411	11756	79719206
Hyperphosphaturia	17.34	16.25	4	13422	111	79730851
Fall	17.34	16.25	35	13391	487594	79243368
Multiple organ dysfunction syndrome	17.34	16.25	52	13374	120194	79610768
Blood alkaline phosphatase increased	17.16	16.25	35	13391	63629	79667333
Arthralgia	17.15	16.25	45	13381	571758	79159204
Hypophosphataemic osteomalacia	17.13	16.25	5	13421	355	79730607
Metastases to lung	16.97	16.25	18	13408	18145	79712817
Glomerular filtration rate decreased	16.93	16.25	20	13406	22682	79708280
Hypokalaemia	16.87	16.25	58	13368	143982	79586980
Sinusitis	16.73	16.25	6	13420	195495	79535467
Septic shock	16.67	16.25	52	13374	122749	79608213
Alkalosis hypokalaemic	16.59	16.25	3	13423	23	79730939
Cancer surgery	16.57	16.25	6	13420	843	79730119
Cytokine release syndrome	16.50	16.25	25	13401	35973	79694989
Malaria	16.34	16.25	5	13421	417	79730545

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J05AF10	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral Agents
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:59897	reverse transcriptase inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Chronic type B viral hepatitis	indication	61977001
Lamivudine-Refractory Chronic Hepatitis B	indication
Lactic acidosis	contraindication	91273001	DOID:3650
Liver function tests abnormal	contraindication	166603001
Steatosis of liver	contraindication	197321007
Impaired renal function disorder	contraindication	197663003
Drug Resistance to Anti-retroviral Therapy	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.56	acidic
pKa2	12.33	acidic
pKa3	13.37	acidic
pKa4	4.58	Basic
pKa5	3.37	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Protein P	Polyprotein	Q9IF40_HBV	INHIBITOR			CHEMBL	CHEMBL
Protein P	Polyprotein	DPOL_HBVB1				WOMBAT-PK
Capsid protein	Unclassified	Q03732_HBV		EC50	9.62	CHEMBL

External reference:

ID	Source
4024911	VUID
N0000171606	NUI
D04008	KEGG_DRUG
4024911	VANDF
C0971023	UMLSCUI
CHEBI:473990	CHEBI
CHEMBL713	ChEMBL_ID
DB00442	DRUGBANK_ID
C413685	MESH_SUPPLEMENTAL_RECORD_UI
135398508	PUBCHEM_CID
5968Y6H45M	UNII
1546027	RXNORM
19722	MMSL
228280	MMSL
67562	MMSL
d05525	MMSL
010730	NDDF
1269008001	SNOMEDCT_US
416248007	SNOMEDCT_US
416644000	SNOMEDCT_US
725853008	SNOMEDCT_US
209216-23-9	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BARACLUDE	HUMAN PRESCRIPTION DRUG LABEL	1	0003-1611	TABLET, FILM COATED	0.50 mg	ORAL	NDA	28 sections
BARACLUDE	HUMAN PRESCRIPTION DRUG LABEL	1	0003-1612	TABLET, FILM COATED	1 mg	ORAL	NDA	28 sections
BARACLUDE	HUMAN PRESCRIPTION DRUG LABEL	1	0003-1614	SOLUTION	0.05 mg	ORAL	NDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	10135-615	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	29 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	10135-616	TABLET, FILM COATED	1 mg	ORAL	ANDA	29 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	16714-717	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	27 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	16714-717	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	27 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	16714-718	TABLET, FILM COATED	1 mg	ORAL	ANDA	27 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	16714-718	TABLET, FILM COATED	1 mg	ORAL	ANDA	27 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	16729-388	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	29 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	16729-389	TABLET, FILM COATED	1 mg	ORAL	ANDA	29 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42291-261	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42291-262	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42806-658	TABLET	0.50 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42806-658	TABLET	0.50 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42806-659	TABLET	1 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	42806-659	TABLET	1 mg	ORAL	ANDA	28 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	50771-013	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	28 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	50771-013	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	28 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	50771-014	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
ENTECAVIR	HUMAN PRESCRIPTION DRUG LABEL	1	50771-014	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51407-064	TABLET, FILM COATED	0.50 mg	ORAL	ANDA	29 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51407-065	TABLET, FILM COATED	1 mg	ORAL	ANDA	29 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51991-895	TABLET	0.50 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51991-895	TABLET	0.50 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51991-896	TABLET	1 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	51991-896	TABLET	1 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	60050-057	TABLET	0.50 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	60050-077	TABLET	1 mg	ORAL	ANDA	31 sections
Entecavir	HUMAN PRESCRIPTION DRUG LABEL	1	60687-216	TABLET	0.50 mg	ORAL	ANDA	26 sections