efavirenz Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antivirals	989	154598-52-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: efavirenz stocrin (-)-Efavirenz sustiva	Efavirenz is a non-nucleoside reverse transcriptase (RT) inhibitor of HIV-1. Efavirenz activity is mediated predominantly by noncompetitive inhibition of HIV-1 reverse transcriptase. HIV-2 RT and human cellular DNA polymerases alpha, beta, gamma, and delta are not inhibited by efavirenz. Molecular weight: 315.68 Formula: C14H9ClF3NO2 CLOGP: 3.73 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 38.33 ALOGS: -4.57 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

efavirenz
stocrin
(-)-Efavirenz
sustiva

Efavirenz is a non-nucleoside reverse transcriptase (RT) inhibitor of HIV-1. Efavirenz activity is mediated predominantly by noncompetitive inhibition of HIV-1 reverse transcriptase. HIV-2 RT and human cellular DNA polymerases alpha, beta, gamma, and delta are not inhibited by efavirenz.

Molecular weight: 315.68
Formula: C14H9ClF3NO2
CLOGP: 3.73
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 38.33
ALOGS: -4.57
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.60	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 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)	27.15 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	42.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Sept. 17, 1998	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
Maternal exposure during pregnancy	1019.11	57.19	245	1507	14618	2341715
Abortion spontaneous	693.01	57.19	177	1575	13268	2343065
Pregnancy	677.08	57.19	157	1595	7792	2348541
Exposure during pregnancy	501.63	57.19	158	1594	25061	2331272
Immune reconstitution inflammatory syndrome	469.95	57.19	85	1667	1159	2355174
Abortion induced	462.47	57.19	99	1653	3337	2352996
Stillbirth	451.08	57.19	84	1668	1357	2354976
Normal newborn	395.40	57.19	74	1678	1226	2355107
Viral mutation identified	374.47	57.19	56	1696	199	2356134
Drug resistance	372.04	57.19	79	1673	2545	2353788
Foetal exposure during pregnancy	312.45	57.19	78	1674	5174	2351159
Virologic failure	285.77	57.19	45	1707	241	2356092
Live birth	265.58	57.19	53	1699	1238	2355095
Lactic acidosis	204.74	57.19	56	1696	5274	2351059
Caesarean section	175.99	57.19	47	1705	4034	2352299
Anaemia	158.54	57.19	75	1677	34717	2321616
Cerebellar ataxia	131.05	57.19	22	1730	184	2356149
Premature delivery	129.15	57.19	35	1717	3165	2353168
Birth mark	122.70	57.19	17	1735	28	2356305
Congenital umbilical hernia	118.10	57.19	17	1735	42	2356291
Lipodystrophy acquired	90.54	57.19	17	1735	282	2356051
Premature baby	88.19	57.19	26	1726	3178	2353155
Pyrexia	87.30	57.19	59	1693	53649	2302684
Pregnancy on contraceptive	83.25	57.19	16	1736	302	2356031
Hepatitis fulminant	82.76	57.19	18	1734	639	2355694
Pathogen resistance	78.29	57.19	18	1734	825	2355508
Foetal death	77.49	57.19	21	1731	1891	2354442
Pulmonary tuberculosis	77.42	57.19	18	1734	867	2355466
Tuberculosis	77.24	57.19	21	1731	1914	2354419
Autoimmune hepatitis	70.48	57.19	19	1733	1676	2354657
Product use issue	70.12	57.19	31	1721	12138	2344195
Vomiting	70.01	57.19	58	1694	71544	2284789
Encephalopathy	67.23	57.19	23	1729	4538	2351795
Treatment noncompliance	62.88	57.19	23	1729	5511	2350822
Premature rupture of membranes	61.43	57.19	15	1737	891	2355442
Drug level increased	61.15	57.19	19	1733	2768	2353565
Rash	59.72	57.19	49	1703	59509	2296824
Drug interaction	59.43	57.19	37	1715	29126	2327207
Jaundice	59.29	57.19	22	1730	5486	2350847
Immune reconstitution inflammatory syndrome associated tuberculosis	59.02	57.19	9	1743	37	2356296
Pregnancy with implant contraceptive	58.64	57.19	13	1739	504	2355829

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
Immune reconstitution inflammatory syndrome	1191.32	40.97	220	2299	1329	1742933
Lipodystrophy acquired	644.93	40.97	106	2413	267	1743995
Drug resistance	392.18	40.97	101	2418	3129	1741133
Foetal exposure during pregnancy	358.56	40.97	109	2410	6250	1738012
Mitochondrial toxicity	276.01	40.97	47	2472	155	1744107
Hyperlipidaemia	271.67	40.97	70	2449	2159	1742103
Pyrexia	258.38	40.97	152	2367	46248	1698014
Viral mutation identified	234.14	40.97	45	2474	333	1743929
Virologic failure	224.80	40.97	44	2475	362	1743900
Progressive external ophthalmoplegia	222.07	40.97	33	2486	27	1744235
Lipoatrophy	186.78	40.97	31	2488	83	1744179
Eyelid ptosis	182.19	40.97	41	2478	696	1743566
Hyperlactacidaemia	177.56	40.97	36	2483	360	1743902
Pulmonary tuberculosis	167.14	40.97	41	2478	1025	1743237
Anaemia	159.16	40.97	95	2424	29362	1714900
Depression	145.86	40.97	74	2445	16595	1727667
Hepatitis	141.64	40.97	51	2468	4904	1739358
Alanine aminotransferase increased	138.90	40.97	65	2454	12213	1732049
Diplopia	135.63	40.97	42	2477	2528	1741734
Hepatic function abnormal	134.30	40.97	54	2465	7020	1737242
Aspartate aminotransferase increased	131.16	40.97	60	2459	10696	1733566
Rash	130.75	40.97	93	2426	38600	1705662
Diarrhoea	121.94	40.97	102	2417	53750	1690512
Gamma-glutamyltransferase increased	121.81	40.97	46	2473	5052	1739210
Vomiting	120.05	40.97	88	2431	38227	1706035
Lactic acidosis	114.33	40.97	44	2475	5085	1739177
Gynaecomastia	113.13	40.97	35	2484	2097	1742165
Drug-induced liver injury	110.33	40.97	38	2481	3199	1741063
Lymphadenopathy	108.79	40.97	40	2479	4074	1740188
Abnormal dreams	108.64	40.97	33	2486	1858	1742404
Hypertriglyceridaemia	104.57	40.97	29	2490	1180	1743082
Hepatic fibrosis	102.77	40.97	25	2494	601	1743661
Acute kidney injury	102.05	40.97	77	2442	34867	1709395
Meningitis cryptococcal	100.54	40.97	22	2497	325	1743937
Renal impairment	99.84	40.97	52	2467	12262	1732000
Blood triglycerides increased	94.36	40.97	32	2487	2568	1741694
Drug interaction	93.73	40.97	67	2452	27891	1716371
General physical health deterioration	85.66	40.97	48	2471	13070	1731192
Hepatotoxicity	85.26	40.97	31	2488	3053	1741209
Nervous system disorder	84.34	40.97	29	2490	2425	1741837
Premature baby	82.93	40.97	30	2489	2912	1741350
Blood alkaline phosphatase increased	82.70	40.97	35	2484	5160	1739102
Kaposi's sarcoma	80.52	40.97	22	2497	845	1743417
Hypercholesterolaemia	77.58	40.97	23	2496	1189	1743073
Nightmare	76.98	40.97	28	2491	2759	1741503
Portal hypertension	75.95	40.97	20	2499	666	1743596
Blood HIV RNULL increased	75.81	40.97	16	2503	197	1744065
Jaundice	74.34	40.97	34	2485	6028	1738234
Proteinuria	72.73	40.97	27	2492	2817	1741445
Weight decreased	72.67	40.97	53	2466	22700	1721562
Asthenia	72.66	40.97	63	2456	34607	1709655
Treatment failure	71.19	40.97	30	2489	4371	1739891
Insomnia	71.08	40.97	46	2473	16230	1728032
Nausea	71.02	40.97	74	2445	51122	1693140
Hepatomegaly	70.12	40.97	23	2496	1662	1742600
Cholestasis	69.52	40.97	28	2491	3637	1740625
Nephropathy toxic	69.49	40.97	23	2496	1709	1742553
Pneumocystis jirovecii pneumonia	69.04	40.97	25	2494	2431	1741831
Cachexia	68.17	40.97	20	2499	996	1743266
Liver disorder	67.18	40.97	31	2488	5605	1738657
Pathogen resistance	66.80	40.97	20	2499	1069	1743193
Cytomegalovirus chorioretinitis	66.05	40.97	16	2503	377	1743885
Renal failure	64.73	40.97	47	2472	19970	1724292
Cryptococcosis	64.21	40.97	15	2504	301	1743961
Osteonecrosis	64.05	40.97	27	2492	3935	1740327
Tuberculosis	63.90	40.97	22	2497	1844	1742418
Neuropathy peripheral	63.47	40.97	35	2484	9218	1735044
Mycobacterium avium complex infection	63.21	40.97	15	2504	323	1743939
HIV infection	61.47	40.97	14	2505	250	1744012
Headache	61.18	40.97	57	2462	34319	1709943
Diabetes mellitus	61.18	40.97	31	2488	6877	1737385
Dyspnoea	59.51	40.97	68	2451	51991	1692271
Hepatitis B	57.76	40.97	19	2500	1384	1742878
Decreased appetite	57.38	40.97	47	2472	23824	1720438
Hypertension	56.89	40.97	43	2476	19405	1724857
Hepatic cirrhosis	56.35	40.97	22	2497	2631	1741631
Abdominal pain	55.21	40.97	44	2475	21446	1722816
Hypophosphataemia	55.00	40.97	18	2501	1290	1742972
Oral candidiasis	54.99	40.97	18	2501	1291	1742971
CD4 lymphocytes decreased	54.36	40.97	14	2505	426	1743836
Hepatosplenomegaly	53.77	40.97	15	2504	622	1743640
Immune reconstitution inflammatory syndrome associated tuberculosis	53.18	40.97	9	2510	28	1744234
Liver injury	52.29	40.97	19	2500	1863	1742399
Ophthalmoplegia	52.08	40.97	12	2507	226	1744036
Hypokalaemia	51.80	40.97	27	2492	6347	1737915
Intracranial pressure increased	51.29	40.97	15	2504	738	1743524
Meningitis tuberculous	50.73	40.97	10	2509	85	1744177
Viral load increased	50.43	40.97	14	2505	570	1743692
Hepatic steatosis	49.88	40.97	20	2499	2564	1741698
Renal tubular disorder	49.07	40.97	15	2504	860	1743402
Blood lactic acid increased	48.67	40.97	15	2504	884	1743378
Sepsis	48.21	40.97	39	2480	19399	1724863
Myocardial infarction	48.17	40.97	45	2474	27129	1717133
Amylase increased	47.72	40.97	16	2503	1236	1743026
Developmental hip dysplasia	47.71	40.97	9	2510	59	1744203
Sleep disorder	47.31	40.97	22	2497	4041	1740221
Confusional state	47.17	40.97	40	2479	21238	1723024
HIV-associated neurocognitive disorder	46.95	40.97	9	2510	65	1744197
Congenital umbilical hernia	46.83	40.97	9	2510	66	1744196
Oesophageal candidiasis	46.23	40.97	13	2506	555	1743707
Blood creatine phosphokinase increased	46.07	40.97	28	2491	8828	1735434
Liver transplant	45.40	40.97	13	2506	593	1743669
Nodular regenerative hyperplasia	45.23	40.97	10	2509	155	1744107
Malaise	44.95	40.97	45	2474	29520	1714742
Dizziness	44.53	40.97	48	2471	34313	1709949
Progressive multifocal leukoencephalopathy	43.50	40.97	16	2503	1623	1742639
Low density lipoprotein increased	43.44	40.97	14	2505	955	1743307
Fanconi syndrome	42.86	40.97	11	2508	330	1743932
Psychotic disorder	42.74	40.97	22	2497	5034	1739228
Hepatitis C	41.68	40.97	18	2501	2778	1741484
Exposure during pregnancy	41.56	40.97	18	2501	2799	1741463
Dyslipidaemia	41.44	40.97	13	2506	812	1743450

Pharmacologic Action:

Source	Code	Description
ATC	J05AG03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Non-nucleoside reverse transcriptase inhibitors
ATC	J05AR06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR11	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA EPC	N0000175463	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
FDA EXT	N0000175460	Non-Nucleoside Analog
FDA MoA	N0000009948	Non-Nucleoside Reverse Transcriptase Inhibitors
FDA MoA	N0000190118	Cytochrome P450 3A Inducers
FDA MoA	N0000187064	Cytochrome P450 2B6 Inducers
FDA MoA	N0000185504	Cytochrome P450 2C9 Inhibitors
FDA MoA	N0000182140	Cytochrome P450 2C19 Inhibitors
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
CHEBI has role	CHEBI:36044	antiviral drug
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D065695	Cytochrome P-450 CYP2B6 Inducers
MeSH PA	D065689	Cytochrome P-450 CYP2C19 Inhibitors
MeSH PA	D065688	Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D019384	Nucleic Acid Synthesis Inhibitors
MeSH PA	D018894	Reverse Transcriptase Inhibitors

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Human immunodeficiency virus infection	indication	86406008	DOID:526
Prevention of HIV Infection after Exposure	off-label use
Osteomalacia	contraindication	4598005	DOID:10573
Hypophosphatemia	contraindication	4996001
Suicidal thoughts	contraindication	6471006
Hypercholesterolemia	contraindication	13644009
Depressive disorder	contraindication	35489007
Fanconi syndrome	contraindication	40488004	DOID:1062
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Aggressive behavior	contraindication	61372001
Chronic type B viral hepatitis	contraindication	61977001
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Chronic hepatitis C	contraindication	128302006
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Paranoid disorder	contraindication	191667009
Steatosis of liver	contraindication	197321007
Mania	contraindication	231494001
Disease of liver	contraindication	235856003	DOID:409
Pathological fracture	contraindication	268029009
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Osteopenia	contraindication	312894000
Breastfeeding (mother)	contraindication	413712001
Obesity	contraindication	414916001	DOID:9970

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.6	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	6642245	Nov. 4, 2020	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	6642245	Nov. 4, 2020	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8716264	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9457036	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9744181	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9018192	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9018192	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9545414	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9545414	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN				WOMBAT-PK
Reverse transcriptase/RNaseH	Enzyme		Q72547_9HIV1	INHIBITOR	Ki	8.52	CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein		POL_HV1A2	INHIBITOR	IC50	8.30	WOMBAT-PK
Reverse transcriptase	Enzyme		Q9WKE8_9HIV1		IC50	8.89	CHEMBL

External reference:

ID	Source
4021133	VUID
N0000148587	NUI
C0674428	UMLSCUI
D00896	KEGG_DRUG
116078005	SNOMEDCT_US
d04355	MMSL
7492	MMSL
195085	RXNORM
4021133	VANDF
387001004	SNOMEDCT_US
007651	NDDF
210786	MMSL
CHEMBL223228	ChEMBL_ID
DB00625	DRUGBANK_ID
JE6H2O27P8	UNII
7718	INN_ID
EFZ	PDB_CHEM_ID
CHEBI:119486	CHEBI
64139	PUBCHEM_CID
C098320	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SUSTIVA	HUMAN PRESCRIPTION DRUG LABEL	1	0056-0470	CAPSULE, GELATIN COATED	50 mg	ORAL	NDA	20 sections
SUSTIVA	HUMAN PRESCRIPTION DRUG LABEL	1	0056-0474	CAPSULE, GELATIN COATED	200 mg	ORAL	NDA	20 sections
SUSTIVA	HUMAN PRESCRIPTION DRUG LABEL	1	0056-0510	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	0378-2233	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Atripla	HUMAN PRESCRIPTION DRUG LABEL	3	15584-0101	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	31722-504	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
SYMFI LO	HUMAN PRESCRIPTION DRUG LABEL	3	49502-425	TABLET, FILM COATED	400 mg	ORAL	NDA	19 sections
SYMFI	HUMAN PRESCRIPTION DRUG LABEL	3	49502-475	TABLET, FILM COATED	600 mg	ORAL	NDA	19 sections
Atripla	HUMAN PRESCRIPTION DRUG LABEL	3	53808-0208	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
SUSTIVA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4668	TABLET, FILM COATED	600 mg	ORAL	NDA	18 sections
Atripla	HUMAN PRESCRIPTION DRUG LABEL	3	54868-5643	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
Atripla Access	HUMAN PRESCRIPTION DRUG LABEL	3	61958-1601	TABLET, FILM COATED	600 mg	ORAL	EXPORT ONLY	20 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	64380-889	TABLET	600 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	64980-406	CAPSULE	50 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	64980-407	CAPSULE	200 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	65862-049	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	65862-104	CAPSULE	50 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	65862-105	CAPSULE	100 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	65862-106	CAPSULE	200 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	65862-774	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	69097-301	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Atripla	HUMAN PRESCRIPTION DRUG LABEL	3	70518-0341	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	70518-1013	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Efavirenz	HUMAN PRESCRIPTION DRUG LABEL	1	70518-1100	TABLET	600 mg	ORAL	ANDA	18 sections