darunavir indications/contra

Stem definitionDrug idCAS RN
HIV protease inhibitors 4143 206361-99-1

Description:

MoleculeDescription

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

Drug dosage:

DoseUnitRoute
1.20 g O

Approvals:

DateAgencyCompanyOrphan
Feb. 12, 2007 EMA
June 23, 2006 FDA JANSSEN PRODS

FDA Adverse Event Reporting System

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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
Foetal exposure during pregnancy 1287.35 39.28 346 4372 15205 3365936
Exposure during pregnancy 988.20 39.28 321 4397 27242 3353899
Virologic failure 794.63 39.28 150 4568 1204 3379937
Immune reconstitution inflammatory syndrome 555.64 39.28 122 4596 2191 3378950
Premature baby 548.70 39.28 151 4567 7102 3374039
Lipodystrophy acquired 442.36 39.28 79 4639 444 3380697
Abortion spontaneous 406.07 39.28 131 4587 10654 3370487
Drug resistance 328.84 39.28 92 4626 4571 3376570
Drug interaction 311.71 39.28 164 4554 46648 3334493
Rash 278.41 39.28 176 4542 70645 3310496
Premature labour 232.40 39.28 59 4659 2004 3379137
Drug reaction with eosinophilia and systemic symptoms 225.54 39.28 78 4640 7817 3373324
Acute kidney injury 221.57 39.28 134 4584 49549 3331592
Rash maculo-papular 207.21 39.28 68 4650 5799 3375342
Pyrexia 190.16 39.28 147 4571 80968 3300173
Diarrhoea 185.68 39.28 161 4557 104187 3276954
Congenital anomaly 176.09 39.28 46 4672 1750 3379391
Foetal growth restriction 174.28 39.28 46 4672 1823 3379318
Progressive external ophthalmoplegia 172.68 39.28 24 4694 8 3381133
Osteoporosis 171.34 39.28 56 4662 4709 3376432
Mitochondrial toxicity 166.73 39.28 30 4688 176 3380965
Cloacal exstrophy 160.11 39.28 22 4696 5 3381136
Hepatocellular injury 159.42 39.28 52 4666 4343 3376798
Bladder agenesis 155.04 39.28 22 4696 12 3381129
Stillbirth 152.76 39.28 40 4678 1535 3379606
Nephrolithiasis 151.55 39.28 56 4662 6780 3374361
Viral load increased 146.55 39.28 34 4684 782 3380359
Dyslipidaemia 143.87 39.28 37 4681 1321 3379820
Gastrointestinal disorder congenital 143.60 39.28 21 4697 19 3381122
Spina bifida 143.09 39.28 29 4689 343 3380798

Pharmacologic Action:

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SourceCodeDescription
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
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)

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DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
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

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.67 acidic
pKa2 1.64 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 150MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 150MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 150MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 150MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 June 23, 2006 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 June 23, 2006 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 June 23, 2006 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 June 23, 2006 DISCN TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 Oct. 21, 2008 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 Oct. 21, 2008 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 Oct. 21, 2008 DISCN TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PREZISTA JANSSEN PRODS N021976 Oct. 21, 2008 DISCN TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 600MG BASE PREZISTA JANSSEN PRODS N021976 Feb. 25, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 600MG BASE PREZISTA JANSSEN PRODS N021976 Feb. 25, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 600MG BASE PREZISTA JANSSEN PRODS N021976 Feb. 25, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 600MG BASE PREZISTA JANSSEN PRODS N021976 Feb. 25, 2008 RX TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 75MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 75MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 75MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 75MG BASE PREZISTA JANSSEN PRODS N021976 Dec. 18, 2008 RX TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 800MG BASE PREZISTA JANSSEN PRODS N021976 Nov. 9, 2012 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 800MG BASE PREZISTA JANSSEN PRODS N021976 Nov. 9, 2012 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 800MG BASE PREZISTA JANSSEN PRODS N021976 Nov. 9, 2012 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
EQ 800MG BASE PREZISTA JANSSEN PRODS N021976 Nov. 9, 2012 RX TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 100MG BASE/ML PREZISTA JANSSEN PRODS N202895 Dec. 16, 2011 RX SUSPENSION ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 100MG BASE/ML PREZISTA JANSSEN PRODS N202895 Dec. 16, 2011 RX SUSPENSION ORAL 7470506 June 23, 2019 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
EQ 100MG BASE/ML PREZISTA JANSSEN PRODS N202895 Dec. 16, 2011 RX SUSPENSION ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
EQ 800MG BASE PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 7470506 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
EQ 800MG BASE PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 8597876 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
EQ 800MG BASE PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 9889115 June 23, 2019 TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
EQ 800MG BASE PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Pol polyprotein Enzyme INHIBITOR Ki 10.85 CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein Ki 9.66 WOMBAT-PK
Protease Enzyme IC50 10.21 CHEMBL

External reference:

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IDSource
4025441 VUID
N0000179778 NUI
C1435444 UMLSCUI
D03656 KEGG_DRUG
33O78XF0BW UNII
635728-49-3 SECONDARY_CAS_RN
d05825 MMSL
460132 RXNORM
4025441 VANDF
423888002 SNOMEDCT_US
424096001 SNOMEDCT_US
N0000179778 NDFRT
N0000175996 NDFRT
011599 NDDF
CHEMBL1323 ChEMBL_ID
CHEMBL1201127 ChEMBL_ID
DB01264 DRUGBANK_ID
213039 PUBCHEM_CID
8305 INN_ID
D000069454 MESH_DESCRIPTOR_UI
CHEBI:367163 CHEBI
017 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 50090-1327 TABLET, FILM COATED 800 mg ORAL NDA 20 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 50090-1491 TABLET, FILM COATED 600 mg ORAL NDA 20 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 50090-1723 TABLET, FILM COATED 800 mg ORAL NDA 19 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 52125-613 TABLET, FILM COATED 800 mg ORAL NDA 20 sections
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 18 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 69189-0566 TABLET, FILM COATED 800 mg ORAL NDA 19 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 70518-0689 TABLET, FILM COATED 600 mg ORAL NDA 20 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 70518-0714 TABLET, FILM COATED 800 mg ORAL NDA 19 sections