Gilead Sciences, Inc. (GILD)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| NDA217899 - GILEAD SCIENCES INC | |||||||
| LIVDELZI | SELADELPAR LYSINE | CAPSULE;ORAL | EQ 10MG BASE | Prescription | |||
| NDA215974 - GILEAD SCIENCES INC | |||||||
| SUNLENCA | LENACAPAVIR SODIUM | TABLET;ORAL | EQ 300MG BASE | Prescription | |||
| NDA215973 - GILEAD SCIENCES INC | |||||||
| SUNLENCA | LENACAPAVIR SODIUM | SOLUTION;SUBCUTANEOUS | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | Prescription | |||
| NDA214787 - GILEAD SCIENCES INC | |||||||
| VEKLURY | REMDESIVIR | POWDER;INTRAVENOUS | 100MG/VIAL | Prescription | |||
| VEKLURY | REMDESIVIR | SOLUTION;INTRAVENOUS | 100MG/20ML (5MG/ML) | Prescription | |||
| NDA214187 - GILEAD SCIENCES INC | |||||||
| EPCLUSA | SOFOSBUVIR; VELPATASVIR | PELLETS;ORAL | 200MG;50MG/PACKET | Prescription | |||
| EPCLUSA | SOFOSBUVIR; VELPATASVIR | PELLETS;ORAL | 150MG;37.5MG/PACKET | Prescription | |||
| NDA212480 - GILEAD SCIENCES INC | |||||||
| SOVALDI | SOFOSBUVIR | PELLETS;ORAL | 200MG/PACKET | Prescription | |||
| SOVALDI | SOFOSBUVIR | PELLETS;ORAL | 150MG/PACKET | Prescription | |||
| NDA212477 - GILEAD SCIENCES INC | |||||||
| HARVONI | LEDIPASVIR; SOFOSBUVIR | PELLETS;ORAL | 45MG;200MG/PACKET | Prescription | |||
| HARVONI | LEDIPASVIR; SOFOSBUVIR | PELLETS;ORAL | 33.75MG;150MG/PACKET | Prescription | |||
| NDA210251 - GILEAD SCIENCES INC | |||||||
| BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | EQ 50MG BASE;200MG;EQ 25MG BASE | Prescription | |||
| BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | EQ 30MG BASE;120MG;EQ 15MG BASE | Prescription | |||
| NDA209195 - GILEAD SCIENCES INC | |||||||
| VOSEVI | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | TABLET;ORAL | 400MG;100MG;100MG | Prescription | |||
| NDA208464 - GILEAD SCIENCES INC | |||||||
| VEMLIDY | TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| NDA208351 - GILEAD SCIENCES INC | |||||||
| ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE;EQ 25MG BASE | Prescription | |||
| NDA208341 - GILEAD SCIENCES INC | |||||||
| EPCLUSA | SOFOSBUVIR; VELPATASVIR | TABLET;ORAL | 400MG;100MG | Prescription | |||
| EPCLUSA | SOFOSBUVIR; VELPATASVIR | TABLET;ORAL | 200MG;50MG | Prescription | |||
| NDA208215 - GILEAD SCIENCES INC | |||||||
| DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE | Prescription | |||
| DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 120MG;EQ 15MG BASE | Prescription | |||
| NDA207561 - GILEAD SCIENCES INC | |||||||
| GENVOYA | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 150MG;150MG;200MG;EQ 10MG BASE | Prescription | |||
| NDA206545 - GILEAD SCIENCES INC | |||||||
| ZYDELIG | IDELALISIB | TABLET;ORAL | 100MG | Prescription | |||
| ZYDELIG | IDELALISIB | TABLET;ORAL | 150MG | Prescription | |||
| NDA205858 - GILEAD SCIENCES INC | |||||||
| ZYDELIG | IDELALISIB | TABLET;ORAL | 150MG | Prescription | |||
| ZYDELIG | IDELALISIB | TABLET;ORAL | 100MG | Prescription | |||
| NDA205834 - GILEAD SCIENCES INC | |||||||
| HARVONI | LEDIPASVIR; SOFOSBUVIR | TABLET;ORAL | 45MG;200MG | Prescription | |||
| HARVONI | LEDIPASVIR; SOFOSBUVIR | TABLET;ORAL | 90MG;400MG | Prescription | |||
| NDA204671 - GILEAD SCIENCES INC | |||||||
| SOVALDI | SOFOSBUVIR | TABLET;ORAL | 200MG | Prescription | |||
| SOVALDI | SOFOSBUVIR | TABLET;ORAL | 400MG | Prescription | |||
| NDA203100 - GILEAD SCIENCES INC | |||||||
| STRIBILD | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 150MG;150MG;200MG;300MG | Prescription | |||
| NDA203094 - GILEAD SCIENCES INC | |||||||
| TYBOST | COBICISTAT | TABLET;ORAL | 150MG | Prescription | |||
| NDA203093 - GILEAD SCIENCES INC | |||||||
| VITEKTA | ELVITEGRAVIR | TABLET;ORAL | 85MG | Discontinued | |||
| VITEKTA | ELVITEGRAVIR | TABLET;ORAL | 150MG | Discontinued | |||
| NDA202123 - GILEAD SCIENCES INC | |||||||
| COMPLERA | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE;300MG | Prescription | |||
| NDA050814 - GILEAD | |||||||
| CAYSTON | AZTREONAM | FOR SOLUTION;INHALATION | 75MG/VIAL | Prescription | |||
| NDA022577 - GILEAD SCIENCES INC | |||||||
| VIREAD | TENOFOVIR DISOPROXIL FUMARATE | POWDER;ORAL | 40MG/SCOOPFUL | Prescription | |||
| NDA022081 - GILEAD | |||||||
| LETAIRIS | AMBRISENTAN | TABLET;ORAL | 5MG | Prescription | |||
| LETAIRIS | AMBRISENTAN | TABLET;ORAL | 10MG | Prescription | |||
| NDA021937 - GILEAD SCIENCES | |||||||
| ATRIPLA | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 600MG;200MG;300MG | Discontinued | |||
| NDA021896 - GILEAD | |||||||
| EMTRIVA | EMTRICITABINE | SOLUTION;ORAL | 10MG/ML | Prescription | |||
| EMTRIVA | EMTRICITABINE | SOLUTION; ORAL | 10MG/ML | Prescription | |||
| NDA021752 - GILEAD | |||||||
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG;300MG | Prescription | |||
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 100MG;150MG | Prescription | |||
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 133MG;200MG | Prescription | |||
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 167MG;250MG | Prescription | |||
| NDA021500 - GILEAD | |||||||
| EMTRIVA | EMTRICITABINE | CAPSULE;ORAL | 200MG | Prescription | |||
| NDA021449 - GILEAD | |||||||
| HEPSERA | ADEFOVIR DIPIVOXIL | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021356 - GILEAD SCIENCES INC | |||||||
| VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 150MG | Prescription | |||
| VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG | Prescription | |||
| VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 250MG | Prescription | |||
| VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | Prescription | |||
| NDA020638 - GILEAD SCIENCES INC | |||||||
| VISTIDE | CIDOFOVIR | INJECTABLE;INJECTION | EQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||