Gilead Sciences RX
FDA Approved Drugs

Gilead Sciences RX

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 44
  • Latest Approval Date Jun 18, 2025
  • Data Source FDA
  • First Approval Date Oct 26, 2001
All
57
View
Unclassified
5
View
Discontinued
8
View
RX
44
View
Company Overview

Company

Gilead Sciences RX

Country

U.S.A

Website

Visit Website

Email

Social Profiles

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Company Snapshot

Gilead Sciences RX

333 Lakeside Drive Foster City, CA 94404

U.S.A

www.gilead.com/ View on Map
FDA Approved Drug Records ( 44 records )
2018
07 Feb
RX Application: 210251

Drug Name

BIKTARVY

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE;200MG;EQ 25MG BASE

Approval Date

2018-02-07

210251 / 1

Active Ingredient

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

210251

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE;200MG;EQ 25MG BASE

Approval Date

2018-02-07

Regulatory Status

RX

2021
07 Oct
RX Application: 210251

Drug Name

BIKTARVY

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE;120MG;EQ 15MG BASE

Approval Date

2021-10-07

210251 / 2

Active Ingredient

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

210251

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE;120MG;EQ 15MG BASE

Approval Date

2021-10-07

Regulatory Status

RX

2010
22 Feb
RX Application: 50814

Drug Name

CAYSTON

Product Number

1

Dosage Form

-

Strength

75MG/VIAL

Approval Date

2010-02-22

50814 / 1

Active Ingredient

AZTREONAM

Application Number

50814

Product Number

1

Dosage Form

-

Strength

75MG/VIAL

Approval Date

2010-02-22

Regulatory Status

RX

2011
10 Aug
RX Application: 202123

Drug Name

COMPLERA

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;300MG

Approval Date

2011-08-10

202123 / 1

Active Ingredient

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

202123

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;300MG

Approval Date

2011-08-10

Regulatory Status

RX

2016
04 Apr
RX Application: 208215

Drug Name

DESCOVY

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2016-04-04

208215 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

208215

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2016-04-04

Regulatory Status

RX

2022
07 Jan
RX Application: 208215

Drug Name

DESCOVY

Product Number

2

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2022-01-07

208215 / 2

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

208215

Product Number

2

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2022-01-07

Regulatory Status

RX

2003
02 Jul
RX Application: 21500

Drug Name

EMTRIVA

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-07-02

21500 / 1

Active Ingredient

EMTRICITABINE

Application Number

21500

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2003-07-02

Regulatory Status

RX

2005
28 Sep
RX Application: 21896

Drug Name

EMTRIVA

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2005-09-28

21896 / 1

Active Ingredient

EMTRICITABINE

Application Number

21896

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2005-09-28

Regulatory Status

RX

2016
28 Jun
RX Application: 208341

Drug Name

EPCLUSA

Product Number

1

Dosage Form

-

Strength

400MG;100MG

Approval Date

2016-06-28

208341 / 1

Active Ingredient

SOFOSBUVIR; VELPATASVIR

Application Number

208341

Product Number

1

Dosage Form

-

Strength

400MG;100MG

Approval Date

2016-06-28

Regulatory Status

RX

2020
19 Mar
RX Application: 208341

Drug Name

EPCLUSA

Product Number

2

Dosage Form

-

Strength

200MG;50MG

Approval Date

2020-03-19

208341 / 2

Active Ingredient

SOFOSBUVIR; VELPATASVIR

Application Number

208341

Product Number

2

Dosage Form

-

Strength

200MG;50MG

Approval Date

2020-03-19

Regulatory Status

RX

2021
10 Jun
RX Application: 214187

Drug Name

EPCLUSA

Product Number

1

Dosage Form

-

Strength

150MG/PACKET;37.5MG/PACKET

Approval Date

2021-06-10

214187 / 1

Active Ingredient

SOFOSBUVIR; VELPATASVIR

Application Number

214187

Product Number

1

Dosage Form

-

Strength

150MG/PACKET;37.5MG/PACKET

Approval Date

2021-06-10

Regulatory Status

RX

2021
10 Jun
RX Application: 214187

Drug Name

EPCLUSA

Product Number

2

Dosage Form

-

Strength

200MG/PACKET;50MG/PACKET

Approval Date

2021-06-10

214187 / 2

Active Ingredient

SOFOSBUVIR; VELPATASVIR

Application Number

214187

Product Number

2

Dosage Form

-

Strength

200MG/PACKET;50MG/PACKET

Approval Date

2021-06-10

Regulatory Status

RX

2015
05 Nov
RX Application: 207561

Drug Name

GENVOYA

Product Number

1

Dosage Form

-

Strength

150MG;150MG;200MG;EQ 10MG BASE

Approval Date

2015-11-05

207561 / 1

Active Ingredient

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

207561

Product Number

1

Dosage Form

-

Strength

150MG;150MG;200MG;EQ 10MG BASE

Approval Date

2015-11-05

Regulatory Status

RX

2014
10 Oct
RX Application: 205834

Drug Name

HARVONI

Product Number

1

Dosage Form

-

Strength

90MG;400MG

Approval Date

2014-10-10

205834 / 1

Active Ingredient

LEDIPASVIR; SOFOSBUVIR

Application Number

205834

Product Number

1

Dosage Form

-

Strength

90MG;400MG

Approval Date

2014-10-10

Regulatory Status

RX

2019
28 Aug
RX Application: 205834

Drug Name

HARVONI

Product Number

2

Dosage Form

-

Strength

45MG;200MG

Approval Date

2019-08-28

205834 / 2

Active Ingredient

LEDIPASVIR; SOFOSBUVIR

Application Number

205834

Product Number

2

Dosage Form

-

Strength

45MG;200MG

Approval Date

2019-08-28

Regulatory Status

RX

2019
28 Aug
RX Application: 212477

Drug Name

HARVONI

Product Number

1

Dosage Form

-

Strength

33.75MG/PACKET;150MG/PACKET

Approval Date

2019-08-28

212477 / 1

Active Ingredient

LEDIPASVIR; SOFOSBUVIR

Application Number

212477

Product Number

1

Dosage Form

-

Strength

33.75MG/PACKET;150MG/PACKET

Approval Date

2019-08-28

Regulatory Status

RX

2019
28 Aug
RX Application: 212477

Drug Name

HARVONI

Product Number

2

Dosage Form

-

Strength

45MG/PACKET;200MG/PACKET

Approval Date

2019-08-28

212477 / 2

Active Ingredient

LEDIPASVIR; SOFOSBUVIR

Application Number

212477

Product Number

2

Dosage Form

-

Strength

45MG/PACKET;200MG/PACKET

Approval Date

2019-08-28

Regulatory Status

RX

2007
15 Jun
RX Application: 22081

Drug Name

LETAIRIS

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-06-15

22081 / 1

Active Ingredient

AMBRISENTAN

Application Number

22081

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-06-15

Regulatory Status

RX

2007
15 Jun
RX Application: 22081

Drug Name

LETAIRIS

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-06-15

22081 / 2

Active Ingredient

AMBRISENTAN

Application Number

22081

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-06-15

Regulatory Status

RX

2024
14 Aug
RX Application: 217899

Drug Name

LIVDELZI

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-08-14

217899 / 1

Active Ingredient

SELADELPAR LYSINE

Application Number

217899

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-08-14

Regulatory Status

RX

2016
01 Mar
RX Application: 208351

Drug Name

ODEFSEY

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2016-03-01

208351 / 1

Active Ingredient

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

208351

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2016-03-01

Regulatory Status

RX

2013
06 Dec
RX Application: 204671

Drug Name

SOVALDI

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2013-12-06

204671 / 1

Active Ingredient

SOFOSBUVIR

Application Number

204671

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2013-12-06

Regulatory Status

RX

2019
28 Aug
RX Application: 204671

Drug Name

SOVALDI

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2019-08-28

204671 / 2

Active Ingredient

SOFOSBUVIR

Application Number

204671

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2019-08-28

Regulatory Status

RX

2019
28 Aug
RX Application: 212480

Drug Name

SOVALDI

Product Number

1

Dosage Form

-

Strength

150MG/PACKET

Approval Date

2019-08-28

212480 / 1

Active Ingredient

SOFOSBUVIR

Application Number

212480

Product Number

1

Dosage Form

-

Strength

150MG/PACKET

Approval Date

2019-08-28

Regulatory Status

RX

2019
28 Aug
RX Application: 212480

Drug Name

SOVALDI

Product Number

2

Dosage Form

-

Strength

200MG/PACKET

Approval Date

2019-08-28

212480 / 2

Active Ingredient

SOFOSBUVIR

Application Number

212480

Product Number

2

Dosage Form

-

Strength

200MG/PACKET

Approval Date

2019-08-28

Regulatory Status

RX

2012
27 Aug
RX Application: 203100

Drug Name

STRIBILD

Product Number

1

Dosage Form

-

Strength

150MG;150MG;200MG;300MG

Approval Date

2012-08-27

203100 / 1

Active Ingredient

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

203100

Product Number

1

Dosage Form

-

Strength

150MG;150MG;200MG;300MG

Approval Date

2012-08-27

Regulatory Status

RX

2022
22 Dec
RX Application: 215973

Drug Name

SUNLENCA

Product Number

1

Dosage Form

-

Strength

EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Approval Date

2022-12-22

215973 / 1

Active Ingredient

LENACAPAVIR SODIUM

Application Number

215973

Product Number

1

Dosage Form

-

Strength

EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Approval Date

2022-12-22

Regulatory Status

RX

2022
22 Dec
RX Application: 215974

Drug Name

SUNLENCA

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-12-22

215974 / 1

Active Ingredient

LENACAPAVIR SODIUM

Application Number

215974

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2022-12-22

Regulatory Status

RX

2004
02 Aug
RX Application: 21752

Drug Name

TRUVADA

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2004-08-02

21752 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

21752

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2004-08-02

Regulatory Status

RX

2016
10 Mar
RX Application: 21752

Drug Name

TRUVADA

Product Number

2

Dosage Form

-

Strength

100MG;150MG

Approval Date

2016-03-10

21752 / 2

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

21752

Product Number

2

Dosage Form

-

Strength

100MG;150MG

Approval Date

2016-03-10

Regulatory Status

RX

2016
10 Mar
RX Application: 21752

Drug Name

TRUVADA

Product Number

3

Dosage Form

-

Strength

133MG;200MG

Approval Date

2016-03-10

21752 / 3

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

21752

Product Number

3

Dosage Form

-

Strength

133MG;200MG

Approval Date

2016-03-10

Regulatory Status

RX

2016
10 Mar
RX Application: 21752

Drug Name

TRUVADA

Product Number

4

Dosage Form

-

Strength

167MG;250MG

Approval Date

2016-03-10

21752 / 4

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

21752

Product Number

4

Dosage Form

-

Strength

167MG;250MG

Approval Date

2016-03-10

Regulatory Status

RX

2020
22 Oct
RX Application: 214787

Drug Name

VEKLURY

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-10-22

214787 / 1

Active Ingredient

REMDESIVIR

Application Number

214787

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-10-22

Regulatory Status

RX

2016
10 Nov
RX Application: 208464

Drug Name

VEMLIDY

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-11-10

208464 / 1

Active Ingredient

TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

208464

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-11-10

Regulatory Status

RX

2001
26 Oct
RX Application: 21356

Drug Name

VIREAD

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2001-10-26

21356 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

21356

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2001-10-26

Regulatory Status

RX

2012
18 Jan
RX Application: 21356

Drug Name

VIREAD

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-01-18

21356 / 2

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

21356

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-01-18

Regulatory Status

RX

2012
18 Jan
RX Application: 21356

Drug Name

VIREAD

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2012-01-18

21356 / 3

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

21356

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2012-01-18

Regulatory Status

RX

2012
18 Jan
RX Application: 21356

Drug Name

VIREAD

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2012-01-18

21356 / 4

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

21356

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

2012-01-18

Regulatory Status

RX

2012
18 Jan
RX Application: 22577

Drug Name

VIREAD

Product Number

1

Dosage Form

-

Strength

40MG/SCOOPFUL

Approval Date

2012-01-18

22577 / 1

Active Ingredient

TENOFOVIR DISOPROXIL FUMARATE

Application Number

22577

Product Number

1

Dosage Form

-

Strength

40MG/SCOOPFUL

Approval Date

2012-01-18

Regulatory Status

RX

2017
18 Jul
RX Application: 209195

Drug Name

VOSEVI

Product Number

1

Dosage Form

-

Strength

400MG;100MG;100MG

Approval Date

2017-07-18

209195 / 1

Active Ingredient

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Application Number

209195

Product Number

1

Dosage Form

-

Strength

400MG;100MG;100MG

Approval Date

2017-07-18

Regulatory Status

RX

2025
18 Jun
RX Application: 220018

Drug Name

YEZTUGO

Product Number

1

Dosage Form

-

Strength

EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Approval Date

2025-06-18

220018 / 1

Active Ingredient

LENACAPAVIR SODIUM

Application Number

220018

Product Number

1

Dosage Form

-

Strength

EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Approval Date

2025-06-18

Regulatory Status

RX

2025
18 Jun
RX Application: 220020

Drug Name

YEZTUGO

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2025-06-18

220020 / 1

Active Ingredient

LENACAPAVIR SODIUM

Application Number

220020

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2025-06-18

Regulatory Status

RX

2014
23 Jul
RX Application: 205858

Drug Name

ZYDELIG

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-07-23

205858 / 1

Active Ingredient

IDELALISIB

Application Number

205858

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2014-07-23

Regulatory Status

RX

2014
23 Jul
RX Application: 205858

Drug Name

ZYDELIG

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2014-07-23

205858 / 2

Active Ingredient

IDELALISIB

Application Number

205858

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2014-07-23

Regulatory Status

RX

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Drug Status Breakdown
44 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

BIKTARVY

Application Number

210251

Product Number

1

Active Ingredient

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Dosage Form

-

Strength

EQ 50MG BASE;200MG;EQ 25MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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