cobicistat Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 4299 | 1004316-88-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A carbamate and thiazole derivative that functions as a CYTOCHROME P450 CYP3A INHIBITOR to enhance the concentration of ANTI-HIV AGENTS, with which it is used in combination, for the treatment of HIV INFECTIONS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.15 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Hosey CM, Chan R, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 27, 2012 | FDA | GILEAD SCIENCES INC |
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 | 131.52 | 33.57 | 41 | 692 | 14822 | 2342530 |
| Abortion spontaneous | 105.99 | 33.57 | 34 | 699 | 13411 | 2343941 |
| Drug interaction | 87.06 | 33.57 | 36 | 697 | 29127 | 2328225 |
| Weight increased | 81.92 | 33.57 | 32 | 701 | 22305 | 2335047 |
| Virologic failure | 77.69 | 33.57 | 13 | 720 | 273 | 2357079 |
| Exposure during pregnancy | 71.36 | 33.57 | 30 | 703 | 25189 | 2332163 |
| Rash | 70.81 | 33.57 | 39 | 694 | 59519 | 2297833 |
| Blood HIV RNULL increased | 61.58 | 33.57 | 9 | 724 | 74 | 2357278 |
| Nausea | 61.57 | 33.57 | 45 | 688 | 112144 | 2245208 |
| Cushing's syndrome | 52.75 | 33.57 | 11 | 722 | 778 | 2356574 |
| Multiple-drug resistance | 52.00 | 33.57 | 9 | 724 | 232 | 2357120 |
| Viral mutation identified | 51.49 | 33.57 | 9 | 724 | 246 | 2357106 |
| Product use complaint | 48.46 | 33.57 | 9 | 724 | 348 | 2357004 |
| Genotype drug resistance test positive | 45.64 | 33.57 | 7 | 726 | 82 | 2357270 |
| Drug resistance | 39.61 | 33.57 | 11 | 722 | 2613 | 2354739 |
| Viral load increased | 37.96 | 33.57 | 7 | 726 | 260 | 2357092 |
| Vomiting | 35.18 | 33.57 | 27 | 706 | 71575 | 2285777 |
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 |
|---|---|---|---|---|---|---|
| Viral load increased | 326.97 | 34.48 | 62 | 2043 | 522 | 1744154 |
| Blood HIV RNULL increased | 179.62 | 34.48 | 32 | 2073 | 181 | 1744495 |
| Weight increased | 165.31 | 34.48 | 68 | 2037 | 11289 | 1733387 |
| Immune reconstitution inflammatory syndrome | 164.20 | 34.48 | 42 | 2063 | 1507 | 1743169 |
| Rash | 161.50 | 34.48 | 99 | 2006 | 38594 | 1706082 |
| Drug interaction | 152.05 | 34.48 | 85 | 2020 | 27873 | 1716803 |
| Nausea | 136.22 | 34.48 | 99 | 2006 | 51097 | 1693579 |
| Blood creatinine increased | 102.64 | 34.48 | 52 | 2053 | 13894 | 1730782 |
| Product dose omission | 97.24 | 34.48 | 59 | 2046 | 22381 | 1722295 |
| Headache | 94.54 | 34.48 | 68 | 2037 | 34308 | 1710368 |
| Diarrhoea | 87.12 | 34.48 | 78 | 2027 | 53774 | 1690902 |
| Drug ineffective | 72.24 | 34.48 | 76 | 2029 | 63725 | 1680951 |
| Genotype drug resistance test positive | 71.75 | 34.48 | 16 | 2089 | 313 | 1744363 |
| Myalgia | 67.27 | 34.48 | 41 | 2064 | 15617 | 1729059 |
| Drug resistance | 66.76 | 34.48 | 25 | 2080 | 3205 | 1741471 |
| Treatment noncompliance | 64.94 | 34.48 | 28 | 2077 | 5173 | 1739503 |
| Product use complaint | 62.29 | 34.48 | 14 | 2091 | 284 | 1744392 |
| Arthralgia | 61.14 | 34.48 | 45 | 2060 | 23399 | 1721277 |
| Glomerular filtration rate decreased | 60.42 | 34.48 | 19 | 2086 | 1438 | 1743238 |
| Fatigue | 58.25 | 34.48 | 61 | 2044 | 50720 | 1693956 |
| Product dispensing error | 57.92 | 34.48 | 19 | 2086 | 1647 | 1743029 |
| CD4 lymphocytes decreased | 51.84 | 34.48 | 13 | 2092 | 427 | 1744249 |
| Abnormal dreams | 51.67 | 34.48 | 18 | 2087 | 1873 | 1742803 |
| Depression | 50.32 | 34.48 | 35 | 2070 | 16634 | 1728042 |
| Therapy cessation | 49.61 | 34.48 | 20 | 2085 | 3119 | 1741557 |
| Vomiting | 47.42 | 34.48 | 48 | 2057 | 38267 | 1706409 |
| Renal tubular disorder | 47.33 | 34.48 | 14 | 2091 | 861 | 1743815 |
| Abdominal discomfort | 44.73 | 34.48 | 26 | 2079 | 9055 | 1735621 |
| Cushing's syndrome | 43.13 | 34.48 | 12 | 2093 | 592 | 1744084 |
| Progressive multifocal leukoencephalopathy | 42.47 | 34.48 | 15 | 2090 | 1624 | 1743052 |
| Amniotic band syndrome | 40.37 | 34.48 | 6 | 2099 | 7 | 1744669 |
| Pruritus | 40.03 | 34.48 | 35 | 2070 | 23187 | 1721489 |
| Dysphagia | 39.49 | 34.48 | 25 | 2080 | 10143 | 1734533 |
| Osteoporosis | 39.42 | 34.48 | 14 | 2091 | 1541 | 1743135 |
| Suicidal ideation | 38.30 | 34.48 | 23 | 2082 | 8495 | 1736181 |
| Insurance issue | 36.86 | 34.48 | 9 | 2096 | 264 | 1744412 |
| Glycosuria | 36.48 | 34.48 | 9 | 2096 | 276 | 1744400 |
| Inability to afford medication | 36.33 | 34.48 | 8 | 2097 | 147 | 1744529 |
| Acute kidney injury | 34.73 | 34.48 | 39 | 2066 | 34905 | 1709771 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V03AX03 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Other therapeutic products |
| ATC | J05AR09 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR14 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR15 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR18 | 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 MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
| FDA EPC | N0000191001 | Cytochrome P450 3A Inhibitor |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
| FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein 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 | D065692 | Cytochrome P-450 CYP3A Inhibitors |
| MeSH PA | D065607 | Cytochrome P-450 Enzyme Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D065606 | Metabolic Side Effects of Drugs and Substances |
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 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 6.58 | Basic |
| pKa2 | 3.62 | Basic |
| pKa3 | 2.45 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 6642245 | Nov. 4, 2020 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 6642245 | Nov. 4, 2020 | TREATMENT OF HIV INFECTION |
| 150MG | 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 |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
| 150MG | 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 |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8716264 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9457036 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9744181 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 7176220 | Aug. 27, 2026 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7176220 | Aug. 27, 2026 | TREATMENT OF HIV INFECTION |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 7635704 | Oct. 26, 2026 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7635704 | Oct. 26, 2026 | TREATMENT OF HIV INFECTION |
| 150MG | TYBOST | GILEAD SCIENCES INC | N203094 | Sept. 24, 2014 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9891239 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION |
| 150MG | 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 |
| 150MG | EVOTAZ | BRISTOL-MYERS SQUIBB | N206353 | 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 |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9891239 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION |
| 150MG | 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 |
| 150MG | 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 |
| 150MG | 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 |
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8633219 | April 24, 2030 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8633219 | April 24, 2030 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG | 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 |
| 150MG | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 150MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | Jan. 27, 2020 | NEW PATIENT POPULATION |
| 150MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | July 17, 2020 | NEW COMBINATION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | Sept. 25, 2020 | NEW PATIENT POPULATION |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | Nov. 5, 2020 | NEW CHEMICAL ENTITY |
| 150MG | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | Nov. 5, 2020 | NEW CHEMICAL ENTITY |
| 150MG | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | Dec. 10, 2021 | DOSING RECOMMENDATION FOR THE USE OF ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FIXED DOSE COMBINATION IN HIV-1 INFECTED ADULT PATIENTS WITH END-STAGE-RENAL DISEASE WHO ARE RECEIVING CHRONIC HEMODIALYSIS |
| 150MG | TYBOST | GILEAD SCIENCES INC | N203094 | Sept. 24, 2014 | RX | TABLET | ORAL | Aug. 22, 2022 | NEW PATIENT POPULATION |
| 150MG | TYBOST | GILEAD SCIENCES INC | N203094 | Sept. 24, 2014 | RX | TABLET | ORAL | Aug. 22, 2026 | INDICATED TO INCREASE SYSTEMIC EXPOSURE OF ATAZANAVIR IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35 KG |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cytochrome P450 3A | Enzyme | INHIBITOR | Ki | 6.03 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| D000069547 | MESH_DESCRIPTOR_UI |
| C3858034 | UMLSCUI |
| D09881 | KEGG_DRUG |
| 714771003 | SNOMEDCT_US |
| 1306284 | RXNORM |
| 014623 | NDDF |
| 28748 | MMSL |
| d07897 | MMSL |
| 4031664 | VANDF |
| 710109003 | SNOMEDCT_US |
| LW2E03M5PG | UNII |
| 9266 | INN_ID |
| DB09065 | DRUGBANK_ID |
| CHEBI:72291 | CHEBI |
| 7535 | IUPHAR_LIGAND_ID |
| CHEMBL2095208 | ChEMBL_ID |
| 25151504 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EVOTAZ | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0003-3641 | TABLET | 150 mg | ORAL | NDA | 18 sections |
| Stribild | HUMAN PRESCRIPTION DRUG LABEL | 4 | 53808-0887 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 19 sections |
| PREZCOBIX | HUMAN PRESCRIPTION DRUG LABEL | 2 | 59676-575 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 19 sections |
| Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 3 | 59676-800 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 20 sections |
| Stribild | HUMAN PRESCRIPTION DRUG LABEL | 4 | 61958-1201 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 20 sections |
| Stribild Access | HUMAN PRESCRIPTION DRUG LABEL | 4 | 61958-1202 | TABLET, FILM COATED | 150 mg | ORAL | Export only | 20 sections |
| Tybost | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-1401 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 19 sections |
| Genvoya | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-1901 | TABLET | 150 mg | ORAL | NDA | 20 sections |
| Stribild | HUMAN PRESCRIPTION DRUG LABEL | 4 | 69189-1201 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 20 sections |
| Genvoya | HUMAN PRESCRIPTION DRUG LABEL | 3 | 70518-0568 | TABLET | 150 mg | ORAL | NDA | 20 sections |