FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
220018NDAGILEAD SCIENCES INC001YEZTUGOSOLUTION;SUBCUTANEOUSEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)LENACAPAVIR SODIUM2025-06-18PrescriptionYes
002YEZTUGOSOLUTION;SUBCUTANEOUS463.5MG/1.5ML(309MG/ML)LENACAPAVIR2025-06-18PrescriptionNo
220020NDAGILEAD SCIENCES INC001YEZTUGOTABLET;ORALEQ 300MG BASELENACAPAVIR SODIUM2025-06-18PrescriptionYes
217899NDAGILEAD SCIENCES INC001LIVDELZICAPSULE;ORALEQ 10MG BASESELADELPAR LYSINE2024-08-14PrescriptionYes
215973NDAGILEAD SCIENCES INC001SUNLENCASOLUTION;SUBCUTANEOUSEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)LENACAPAVIR SODIUM2022-12-22PrescriptionYes
215974NDAGILEAD SCIENCES INC001SUNLENCATABLET;ORALEQ 300MG BASELENACAPAVIR SODIUM2022-12-22PrescriptionYes
214187NDAGILEAD SCIENCES INC001EPCLUSAPELLETS;ORAL150MG;37.5MG/PACKETSOFOSBUVIR; VELPATASVIR2021-06-10PrescriptionNo
002EPCLUSAPELLETS;ORAL200MG;50MG/PACKETSOFOSBUVIR; VELPATASVIR2021-06-10PrescriptionYes
214787NDAGILEAD SCIENCES INC001VEKLURYPOWDER;INTRAVENOUS100MG/VIALREMDESIVIR2020-10-22PrescriptionYes
002VEKLURYSOLUTION;INTRAVENOUS100MG/20ML (5MG/ML)REMDESIVIR2020-10-22DiscontinuedNo
212477NDAGILEAD SCIENCES INC001HARVONIPELLETS;ORAL33.75MG;150MG/PACKETLEDIPASVIR; SOFOSBUVIR2019-08-28PrescriptionNo
002HARVONIPELLETS;ORAL45MG;200MG/PACKETLEDIPASVIR; SOFOSBUVIR2019-08-28PrescriptionYes
212480NDAGILEAD SCIENCES INC001SOVALDIPELLETS;ORAL150MG/PACKETSOFOSBUVIR2019-08-28PrescriptionNo
002SOVALDIPELLETS;ORAL200MG/PACKETSOFOSBUVIR2019-08-28PrescriptionYes
210251NDAGILEAD SCIENCES INC001BIKTARVYTABLET;ORALEQ 50MG BASE;200MG;EQ 25MG BASEBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE2018-02-07PrescriptionYes
002BIKTARVYTABLET;ORALEQ 30MG BASE;120MG;EQ 15MG BASEBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE2018-02-07PrescriptionNo
209195NDAGILEAD SCIENCES INC001VOSEVITABLET;ORAL400MG;100MG;100MGSOFOSBUVIR; VELPATASVIR; VOXILAPREVIR2017-07-18PrescriptionYes
208464NDAGILEAD SCIENCES INC001VEMLIDYTABLET;ORALEQ 25MG BASETENOFOVIR ALAFENAMIDE FUMARATE2016-11-10PrescriptionYes
208341NDAGILEAD SCIENCES INC001EPCLUSATABLET;ORAL400MG;100MGSOFOSBUVIR; VELPATASVIR2016-06-28PrescriptionYes
002EPCLUSATABLET;ORAL200MG;50MGSOFOSBUVIR; VELPATASVIR2016-06-28PrescriptionNo
208215NDAGILEAD SCIENCES INC001DESCOVYTABLET;ORAL200MG;EQ 25MG BASEEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE2016-04-04PrescriptionYes
002DESCOVYTABLET;ORAL120MG;EQ 15MG BASEEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE2016-04-04PrescriptionNo
208351NDAGILEAD SCIENCES INC001ODEFSEYTABLET;ORAL200MG;EQ 25MG BASE;EQ 25MG BASEEMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE2016-03-01PrescriptionYes
207561NDAGILEAD SCIENCES INC001GENVOYATABLET;ORAL150MG;150MG;200MG;EQ 10MG BASECOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE2015-11-05PrescriptionYes
205834NDAGILEAD SCIENCES INC001HARVONITABLET;ORAL90MG;400MGLEDIPASVIR; SOFOSBUVIR2014-10-10PrescriptionYes
002HARVONITABLET;ORAL45MG;200MGLEDIPASVIR; SOFOSBUVIR2014-10-10PrescriptionNo
203093NDAGILEAD SCIENCES INC001VITEKTATABLET;ORAL85MGELVITEGRAVIR2014-09-24DiscontinuedNo
002VITEKTATABLET;ORAL150MGELVITEGRAVIR2014-09-24DiscontinuedNo
203094NDAGILEAD SCIENCES INC001TYBOSTTABLET;ORAL150MGCOBICISTAT2014-09-24PrescriptionYes
002TYBOSTTABLET;ORAL90MGCOBICISTAT2014-09-24PrescriptionNo
205858NDAGILEAD SCIENCES INC001ZYDELIGTABLET;ORAL100MGIDELALISIB2014-07-23PrescriptionNo
002ZYDELIGTABLET;ORAL150MGIDELALISIB2014-07-23PrescriptionYes
206545NDAGILEAD SCIENCES INC001ZYDELIGTABLET;ORAL100MGIDELALISIB2014-07-23PrescriptionNo
002ZYDELIGTABLET;ORAL150MGIDELALISIB2014-07-23PrescriptionNo
204671NDAGILEAD SCIENCES INC001SOVALDITABLET;ORAL400MGSOFOSBUVIR2013-12-06PrescriptionYes
002SOVALDITABLET;ORAL200MGSOFOSBUVIR2013-12-06PrescriptionNo
203100NDAGILEAD SCIENCES INC001STRIBILDTABLET;ORAL150MG;150MG;200MG;300MGCOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2012-08-27PrescriptionYes
022577NDAGILEAD SCIENCES INC001VIREADPOWDER;ORAL40MG/SCOOPFULTENOFOVIR DISOPROXIL FUMARATE2012-01-18PrescriptionYes
202123NDAGILEAD SCIENCES INC001COMPLERATABLET;ORAL200MG;EQ 25MG BASE;300MGEMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE2011-08-10PrescriptionYes
050814NDAGILEAD001CAYSTONFOR SOLUTION;INHALATION75MG/VIALAZTREONAM2010-02-22PrescriptionYes
022081NDAGILEAD001LETAIRISTABLET;ORAL5MGAMBRISENTAN2007-06-15PrescriptionNo
002LETAIRISTABLET;ORAL10MGAMBRISENTAN2007-06-15PrescriptionYes
021937NDAGILEAD SCIENCES001ATRIPLATABLET;ORAL600MG;200MG;300MGEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2006-07-12DiscontinuedNo
021896NDAGILEAD001EMTRIVASOLUTION;ORAL10MG/MLEMTRICITABINE2005-09-28PrescriptionYes
002EMTRIVASOLUTION; ORAL10MG/MLEMTRICITABINE2005-09-28PrescriptionNo
021752NDAGILEAD001TRUVADATABLET;ORAL200MG;300MGEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2004-08-02PrescriptionYes
002TRUVADATABLET;ORAL100MG;150MGEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2004-08-02PrescriptionNo
003TRUVADATABLET;ORAL133MG;200MGEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2004-08-02PrescriptionNo
004TRUVADATABLET;ORAL167MG;250MGEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE2004-08-02PrescriptionNo
021500NDAGILEAD001EMTRIVACAPSULE;ORAL200MGEMTRICITABINE2003-07-02PrescriptionYes
021449NDAGILEAD001HEPSERATABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ADEFOVIR DIPIVOXIL2002-09-20DiscontinuedNo
021356NDAGILEAD SCIENCES INC001VIREADTABLET;ORAL300MGTENOFOVIR DISOPROXIL FUMARATE2001-10-26PrescriptionYes
002VIREADTABLET;ORAL150MGTENOFOVIR DISOPROXIL FUMARATE2001-10-26PrescriptionNo
003VIREADTABLET;ORAL200MGTENOFOVIR DISOPROXIL FUMARATE2001-10-26PrescriptionNo
004VIREADTABLET;ORAL250MGTENOFOVIR DISOPROXIL FUMARATE2001-10-26PrescriptionNo
020638NDAGILEAD SCIENCES INC001VISTIDESOLUTION;INTRAVENOUSEQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CIDOFOVIR1996-06-26DiscontinuedNo