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

Stem definition	Drug id	CAS RN
HIV protease inhibitors	4143	206361-99-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: darunavir darunavir ethanolate prezista TMC-114 TMC 114 darunavir ethnolate	An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS. Molecular weight: 547.67 Formula: C27H37N3O7S CLOGP: 2.89 LIPINSKI: 1 HAC: 10 HDO: 3 TPSA: 140.42 ALOGS: -3.91 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

darunavir
darunavir ethanolate
prezista
TMC-114
TMC 114
darunavir ethnolate

An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.

Molecular weight: 547.67
Formula: C27H37N3O7S
CLOGP: 2.89
LIPINSKI: 1
HAC: 10
HDO: 3
TPSA: 140.42
ALOGS: -3.91
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.20	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.15 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1.20 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	20.87 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	37 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	7.81 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Feb. 12, 2007	EMA
June 23, 2006	FDA	JANSSEN PRODS

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
Exposure during pregnancy	1523.54	64.41	376	1456	24843	2331410
Foetal exposure during pregnancy	826.98	64.41	173	1659	5079	2351174
Abortion spontaneous	719.29	64.41	184	1648	13261	2342992
Maternal exposure during pregnancy	421.83	64.41	124	1708	14739	2341514
Live birth	311.61	64.41	61	1771	1230	2355023
Premature baby	309.30	64.41	71	1761	3133	2353120
Premature labour	298.81	64.41	64	1768	2042	2354211
Premature delivery	225.46	64.41	55	1777	3145	2353108
Foetal death	214.76	64.41	48	1784	1864	2354389
Foetal growth restriction	209.78	64.41	43	1789	1097	2355156
Immune reconstitution inflammatory syndrome	188.74	64.41	40	1792	1204	2355049
Rash	178.44	64.41	98	1734	59460	2296793
Lipodystrophy acquired	148.40	64.41	26	1806	273	2355980
Stillbirth	139.13	64.41	32	1800	1409	2354844
Hepatocellular injury	137.24	64.41	39	1793	4016	2352237
Abortion induced	129.71	64.41	36	1796	3400	2352853
Caesarean section	128.02	64.41	37	1795	4044	2352209
Congenital naevus	123.94	64.41	17	1815	23	2356230
Treatment noncompliance	121.08	64.41	38	1794	5496	2350757
Spina bifida	116.99	64.41	19	1813	120	2356133
Drug interaction	115.39	64.41	58	1774	29105	2327148
Viral mutation identified	112.06	64.41	20	1812	235	2356018
Sudden infant death syndrome	110.74	64.41	17	1815	70	2356183
Acoustic stimulation tests abnormal	107.11	64.41	15	1817	26	2356227
Low set ears	105.84	64.41	16	1816	58	2356195
Premature rupture of membranes	103.01	64.41	23	1809	883	2355370
Supernumerary nipple	101.66	64.41	13	1819	5	2356248
Drug resistance	101.33	64.41	28	1804	2596	2353657
Anal atresia	96.53	64.41	15	1817	68	2356185
Rash maculo-papular	96.32	64.41	30	1802	4222	2352031
Cloacal exstrophy	94.29	64.41	12	1820	4	2356249
Viral load increased	91.70	64.41	17	1815	250	2356003
Congenital heart valve disorder	90.04	64.41	13	1819	31	2356222
Eosinophilia	88.99	64.41	26	1806	2944	2353309
Bladder agenesis	87.75	64.41	11	1821	2	2356251
Congenital pulmonary valve disorder	86.35	64.41	12	1820	19	2356234
Congenital genital malformation	84.17	64.41	11	1821	7	2356246
Cholestasis of pregnancy	83.40	64.41	14	1818	111	2356142
Oligohydramnios	80.36	64.41	19	1813	941	2355312
Genitalia external ambiguous	80.13	64.41	11	1821	15	2356238
Cerebral ventricle dilatation	76.76	64.41	14	1818	187	2356066
Gastrointestinal disorder congenital	76.74	64.41	10	1822	6	2356247
Ventricular hypertrophy	76.46	64.41	17	1815	639	2355614
Congenital anomaly	75.80	64.41	16	1816	469	2355784
Tethered cord syndrome	75.67	64.41	11	1821	28	2356225
Meningomyelocele	75.28	64.41	12	1820	66	2356187
Dermatitis exfoliative generalised	74.89	64.41	15	1817	337	2355916
Cushing's syndrome	73.33	64.41	17	1815	772	2355481
Meconium stain	72.94	64.41	11	1821	39	2356214
Maternal drugs affecting foetus	71.36	64.41	19	1813	1528	2354725
Skull malformation	70.84	64.41	12	1820	101	2356152
Cardiac murmur	70.13	64.41	19	1813	1632	2354621
Caudal regression syndrome	70.13	64.41	10	1822	21	2356232
Exomphalos	69.89	64.41	11	1821	55	2356198
Neonatal respiratory arrest	68.92	64.41	10	1822	25	2356228
Anaemia	68.79	64.41	44	1788	34748	2321505
Pulmonary valve sclerosis	65.15	64.41	8	1824	0	2356253

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
Foetal exposure during pregnancy	625.78	33.10	176	2952	6183	1737470
Immune reconstitution inflammatory syndrome	581.95	33.10	126	3002	1423	1742230
Lipodystrophy acquired	355.35	33.10	66	3062	307	1743346
Progressive external ophthalmoplegia	260.51	33.10	39	3089	21	1743632
Drug interaction	252.90	33.10	136	2992	27822	1715831
Diarrhoea	239.35	33.10	166	2962	53686	1689967
Mitochondrial toxicity	239.29	33.10	43	3085	159	1743494
Premature baby	202.62	33.10	62	3066	2880	1740773
Eyelid ptosis	194.40	33.10	45	3083	692	1742961
Rash	180.07	33.10	123	3005	38570	1705083
Drug reaction with eosinophilia and systemic symptoms	169.51	33.10	62	3066	5008	1738645
Acute kidney injury	155.14	33.10	108	3020	34836	1708817
Viral load increased	145.21	33.10	34	3094	550	1743103
Nausea	142.99	33.10	120	3008	51076	1692577
Osteoporosis	142.92	33.10	41	3087	1514	1742139
Nephrolithiasis	130.34	33.10	48	3080	3944	1739709
Pyrexia	125.80	33.10	107	3021	46293	1697360
Diplopia	122.63	33.10	41	3087	2529	1741124
Virologic failure	118.86	33.10	27	3101	379	1743274
Renal tubular disorder	117.08	33.10	31	3097	844	1742809
Renal impairment	116.64	33.10	62	3066	12252	1731401
Rash maculo-papular	115.27	33.10	43	3085	3660	1739993
Hypertriglyceridaemia	111.63	33.10	32	3096	1177	1742476
Drug resistance	95.03	33.10	36	3092	3194	1740459
Hepatitis	93.11	33.10	40	3088	4915	1738738
Vomiting	92.84	33.10	83	3045	38232	1705421
Mycobacterium avium complex infection	91.00	33.10	21	3107	317	1743336
Thrombocytopenia	87.76	33.10	63	3065	21186	1722467
Renal failure	81.84	33.10	59	3069	19958	1723695
Dyslipidaemia	81.38	33.10	23	3105	802	1742851
Low birth weight baby	79.73	33.10	23	3105	864	1742789
Osteonecrosis	77.78	33.10	33	3095	3929	1739724
Hyperlipidaemia	73.42	33.10	27	3101	2202	1741451
Stevens-Johnson syndrome	72.73	33.10	30	3098	3327	1740326
Hepatocellular injury	70.43	33.10	29	3099	3202	1740451
Pruritus	69.78	33.10	57	3071	23165	1720488
Headache	68.75	33.10	67	3061	34309	1709344
Blood creatinine increased	68.41	33.10	46	3082	13900	1729753
Foetal growth restriction	67.15	33.10	19	3109	665	1742988
Weight increased	66.83	33.10	42	3086	11315	1732338
Insomnia	66.54	33.10	48	3080	16228	1727425
Myocardial infarction	65.94	33.10	59	3069	27115	1716538
Hemivertebra	64.54	33.10	11	3117	27	1743626
Viral mutation identified	63.22	33.10	16	3112	362	1743291
Genital herpes simplex	61.13	33.10	10	3118	17	1743636
Cholestasis	57.24	33.10	26	3102	3639	1740014
Neuropathy peripheral	56.39	33.10	35	3093	9218	1734435
Weight decreased	56.34	33.10	50	3078	22703	1720950
Blood HIV RNULL increased	56.09	33.10	13	3115	200	1743453
Cushing's syndrome	55.79	33.10	16	3112	588	1743065
Blood cholesterol increased	55.40	33.10	24	3104	3002	1740651
Polydactyly	55.26	33.10	13	3115	214	1743439
Eosinophilia	55.02	33.10	25	3103	3502	1740151
Liver function test abnormal	54.58	33.10	29	3099	5697	1737956
Genital herpes	52.87	33.10	11	3117	99	1743554
Fatigue	52.03	33.10	70	3058	50711	1692942
Congenital mitral valve incompetence	51.99	33.10	9	3119	25	1743628
Treatment noncompliance	51.44	33.10	27	3101	5174	1738479
CD4 lymphocytes decreased	51.35	33.10	14	3114	426	1743227
HIV-associated neurocognitive disorder	51.06	33.10	10	3118	64	1743589
Hepatitis cholestatic	50.99	33.10	18	3110	1303	1742350
Anaemia	50.74	33.10	53	3075	29404	1714249
Embolism	50.00	33.10	17	3111	1100	1742553
Hepatitis B	49.93	33.10	18	3110	1385	1742268
Oesophageal atresia	49.80	33.10	10	3118	74	1743579
Diabetes mellitus	49.49	33.10	29	3099	6879	1736774
Liver disorder	49.40	33.10	27	3101	5609	1738044
Abdominal pain	48.81	33.10	45	3083	21445	1722208
Cytomegalovirus chorioretinitis	48.18	33.10	13	3115	380	1743273
Exposure during pregnancy	47.22	33.10	21	3107	2796	1740857
Syphilis	47.11	33.10	10	3118	100	1743553
Congenital anomaly	47.08	33.10	13	3115	415	1743238
Product use complaint	46.81	33.10	12	3116	286	1743367
Pneumocystis jirovecii pneumonia	46.67	33.10	20	3108	2436	1741217
Blood triglycerides increased	45.57	33.10	20	3108	2580	1741073
Hepatic failure	45.52	33.10	26	3102	5877	1737776
Hypercholesterolaemia	44.83	33.10	16	3112	1196	1742457
Ophthalmoplegia	44.41	33.10	11	3117	227	1743426
Spine malformation	42.69	33.10	8	3120	39	1743614
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma	42.39	33.10	7	3121	13	1743640
HIV lipodystrophy	41.71	33.10	6	3122	1	1743652
Proteinuria	40.72	33.10	19	3109	2825	1740828
Congenital hydronephrosis	40.38	33.10	9	3119	115	1743538
Malaise	40.17	33.10	47	3081	29518	1714135
Pancreatitis acute	39.78	33.10	21	3107	4066	1739587
Jaundice	39.64	33.10	24	3104	6038	1737615
Superior mesenteric artery syndrome	39.56	33.10	7	3121	23	1743630
Blood bilirubin increased	39.11	33.10	24	3104	6186	1737467
Pancytopenia	38.57	33.10	30	3098	11327	1732326
Anogenital dysplasia	38.48	33.10	7	3121	28	1743625
Drug-induced liver injury	38.38	33.10	19	3109	3218	1740435
Amniotic band syndrome	37.99	33.10	6	3122	7	1743646
Gene mutation	37.93	33.10	9	3119	154	1743499
Maternal drugs affecting foetus	37.86	33.10	14	3114	1157	1742496
Hyperglycaemia	37.82	33.10	22	3106	5143	1738510
Candida infection	37.38	33.10	16	3112	1942	1741711
Asthenia	37.28	33.10	49	3079	34621	1709032
Neutropenia	37.16	33.10	36	3092	18224	1725429
Progressive multifocal leukoencephalopathy	36.68	33.10	15	3113	1624	1742029
Myalgia	35.93	33.10	33	3095	15625	1728028
Hospitalisation	35.62	33.10	30	3098	12670	1730983
Pathogen resistance	35.14	33.10	13	3115	1076	1742577
Hepatitis C	34.90	33.10	17	3111	2779	1740874
Glomerular filtration rate decreased	34.89	33.10	14	3114	1443	1742210
HIV associated nephropathy	34.84	33.10	6	3122	16	1743637
Extraocular muscle paresis	34.15	33.10	7	3121	58	1743595
Hepatic function abnormal	33.83	33.10	23	3105	7051	1736602
Agranulocytosis	33.75	33.10	18	3110	3558	1740095
Blood creatine phosphokinase increased	33.60	33.10	25	3103	8831	1734822
Coccidioidomycosis	33.54	33.10	8	3120	140	1743513
Aspartate aminotransferase increased	33.48	33.10	27	3101	10729	1732924

Pharmacologic Action:

Source	Code	Description
ATC	J05AE10	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors
ATC	J05AR14	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR22	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR26	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA EPC	N0000175889	Protease Inhibitor
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D017320	HIV Protease Inhibitors
MeSH PA	D011480	Protease Inhibitors
CHEBI has role	CHEBI:36044	antiviral drug

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Human immunodeficiency virus infection	indication	86406008	DOID:526
Coronavirus infection	off-label use	186747009
Hypercholesterolemia	contraindication	13644009
Cirrhosis of liver	contraindication	19943007	DOID:5082
Hereditary factor VIII deficiency disease	contraindication	28293008	DOID:12134
Hereditary factor IX deficiency disease	contraindication	41788008	DOID:12259
Hepatic failure	contraindication	59927004
Chronic type B viral hepatitis	contraindication	61977001
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Chronic hepatitis C	contraindication	128302006
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Hypertriglyceridemia	contraindication	302870006
Breastfeeding (mother)	contraindication	413712001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.67	acidic
pKa2	1.64	Basic

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
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	6642245	Nov. 4, 2020	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	7803788	Feb. 2, 2022	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
800MG	PREZCOBIX	JANSSEN PRODS	N205395	Jan. 29, 2015	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8754065	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	9296769	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	July 17, 2020	NEW COMBINATION
800MG	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	Nov. 5, 2020	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Pol polyprotein	Enzyme	Q72874_9HIV1	INHIBITOR	Ki	10.85	CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein	POL_HV1BR		Ki	9.66	WOMBAT-PK
Protease	Enzyme	Q9YQ12_9HIV1		IC50	10.21	CHEMBL

External reference:

ID	Source
D000069454	MESH_DESCRIPTOR_UI
4025441	VUID
N0000179778	NUI
C1435444	UMLSCUI
D03656	KEGG_DRUG
33O78XF0BW	UNII
635728-49-3	SECONDARY_CAS_RN
424096001	SNOMEDCT_US
d05825	MMSL
460132	RXNORM
4025441	VANDF
423888002	SNOMEDCT_US
011599	NDDF
CHEMBL1323	ChEMBL_ID
017	PDB_CHEM_ID
DB01264	DRUGBANK_ID
CHEBI:367163	CHEBI
8305	INN_ID
CHEMBL1201127	ChEMBL_ID
213039	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0672	TABLET, FILM COATED	400 mg	ORAL	NDA	18 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0773	TABLET, FILM COATED	600 mg	ORAL	NDA	18 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5969	TABLET, FILM COATED	400 mg	ORAL	NDA	19 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6369	TABLET, FILM COATED	600 mg	ORAL	NDA	19 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-562	TABLET, FILM COATED	600 mg	ORAL	NDA	20 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-563	TABLET, FILM COATED	75 mg	ORAL	NDA	20 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-564	TABLET, FILM COATED	150 mg	ORAL	NDA	20 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-565	SUSPENSION	100 mg	ORAL	NDA	20 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-566	TABLET, FILM COATED	800 mg	ORAL	NDA	20 sections
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	59676-575	TABLET, FILM COATED	800 mg	ORAL	NDA	19 sections
Symtuza	HUMAN PRESCRIPTION DRUG LABEL	3	59676-800	TABLET, FILM COATED	800 mg	ORAL	NDA	20 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	70518-1483	TABLET, FILM COATED	800 mg	ORAL	NDA	20 sections