GSK RX
FDA Approved Drugs

GSK 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 67
  • Latest Approval Date Jun 17, 2026
  • Data Source FDA
  • First Approval Date Dec 27, 1994
All
377
View
Unclassified
14
View
Discontinued
296
View
RX
67
View
Company Overview

Company

GSK RX

Country

United Kingdom

Website

Visit Website

Email

Social Profiles

Company Snapshot

GSK RX

980 Great West Road, Brentford, Middlesex TW8 9GS England

United Kingdom

www.gsk.com:443/en-gb/ View on Map
FDA Approved Drug Records ( 67 records )
2000
24 Aug
RX Application: 21077

Drug Name

ADVAIR DISKUS 100/50

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

21077 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21077

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

Regulatory Status

RX

2000
24 Aug
RX Application: 21077

Drug Name

ADVAIR DISKUS 250/50

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

21077 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21077

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

Regulatory Status

RX

2000
24 Aug
RX Application: 21077

Drug Name

ADVAIR DISKUS 500/50

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

21077 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21077

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2000-08-24

Regulatory Status

RX

2006
08 Jun
RX Application: 21254

Drug Name

ADVAIR HFA

Product Number

1

Dosage Form

-

Strength

0.045MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

21254 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21254

Product Number

1

Dosage Form

-

Strength

0.045MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

Regulatory Status

RX

2006
08 Jun
RX Application: 21254

Drug Name

ADVAIR HFA

Product Number

2

Dosage Form

-

Strength

0.115MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

21254 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21254

Product Number

2

Dosage Form

-

Strength

0.115MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

Regulatory Status

RX

2006
08 Jun
RX Application: 21254

Drug Name

ADVAIR HFA

Product Number

3

Dosage Form

-

Strength

0.23MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

21254 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

21254

Product Number

3

Dosage Form

-

Strength

0.23MG/INH;EQ 0.021MG BASE/INH

Approval Date

2006-06-08

Regulatory Status

RX

2013
18 Dec
RX Application: 203975

Drug Name

ANORO ELLIPTA

Product Number

1

Dosage Form

-

Strength

EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2013-12-18

203975 / 1

Active Ingredient

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Application Number

203975

Product Number

1

Dosage Form

-

Strength

EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2013-12-18

Regulatory Status

RX

2014
20 Aug
RX Application: 205625

Drug Name

ARNUITY ELLIPTA

Product Number

1

Dosage Form

-

Strength

0.1MG/INH

Approval Date

2014-08-20

205625 / 1

Active Ingredient

FLUTICASONE FUROATE

Application Number

205625

Product Number

1

Dosage Form

-

Strength

0.1MG/INH

Approval Date

2014-08-20

Regulatory Status

RX

2014
20 Aug
RX Application: 205625

Drug Name

ARNUITY ELLIPTA

Product Number

2

Dosage Form

-

Strength

0.2MG/INH

Approval Date

2014-08-20

205625 / 2

Active Ingredient

FLUTICASONE FUROATE

Application Number

205625

Product Number

2

Dosage Form

-

Strength

0.2MG/INH

Approval Date

2014-08-20

Regulatory Status

RX

2018
17 May
RX Application: 205625

Drug Name

ARNUITY ELLIPTA

Product Number

3

Dosage Form

-

Strength

0.05MG/INH

Approval Date

2018-05-17

205625 / 3

Active Ingredient

FLUTICASONE FUROATE

Application Number

205625

Product Number

3

Dosage Form

-

Strength

0.05MG/INH

Approval Date

2018-05-17

Regulatory Status

RX

2025
25 Mar
RX Application: 218230

Drug Name

BLUJEPA

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2025-03-25

218230 / 1

Active Ingredient

GEPOTIDACIN MESYLATE

Application Number

218230

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2025-03-25

Regulatory Status

RX

2013
10 May
RX Application: 204275

Drug Name

BREO ELLIPTA

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.025MG BASE/INH

Approval Date

2013-05-10

204275 / 1

Active Ingredient

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Application Number

204275

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.025MG BASE/INH

Approval Date

2013-05-10

Regulatory Status

RX

2015
30 Apr
RX Application: 204275

Drug Name

BREO ELLIPTA

Product Number

2

Dosage Form

-

Strength

0.2MG/INH;EQ 0.025MG BASE/INH

Approval Date

2015-04-30

204275 / 2

Active Ingredient

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Application Number

204275

Product Number

2

Dosage Form

-

Strength

0.2MG/INH;EQ 0.025MG BASE/INH

Approval Date

2015-04-30

Regulatory Status

RX

2023
12 May
RX Application: 204275

Drug Name

BREO ELLIPTA

Product Number

3

Dosage Form

-

Strength

0.05MG/INH;EQ 0.025MG BASE/INH

Approval Date

2023-05-12

204275 / 3

Active Ingredient

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Application Number

204275

Product Number

3

Dosage Form

-

Strength

0.05MG/INH;EQ 0.025MG BASE/INH

Approval Date

2023-05-12

Regulatory Status

RX

2021
01 Jun
RX Application: 214900

Drug Name

BREXAFEMME

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-06-01

214900 / 1

Active Ingredient

IBREXAFUNGERP CITRATE

Application Number

214900

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2021-06-01

Regulatory Status

RX

2000
29 Sep
RX Application: 20833

Drug Name

FLOVENT DISKUS 100

Product Number

2

Dosage Form

-

Strength

0.1MG/INH

Approval Date

2000-09-29

20833 / 2

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20833

Product Number

2

Dosage Form

-

Strength

0.1MG/INH

Approval Date

2000-09-29

Regulatory Status

RX

2000
29 Sep
RX Application: 20833

Drug Name

FLOVENT DISKUS 250

Product Number

3

Dosage Form

-

Strength

0.25MG/INH

Approval Date

2000-09-29

20833 / 3

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20833

Product Number

3

Dosage Form

-

Strength

0.25MG/INH

Approval Date

2000-09-29

Regulatory Status

RX

2000
29 Sep
RX Application: 20833

Drug Name

FLOVENT DISKUS 50

Product Number

1

Dosage Form

-

Strength

0.05MG/INH

Approval Date

2000-09-29

20833 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20833

Product Number

1

Dosage Form

-

Strength

0.05MG/INH

Approval Date

2000-09-29

Regulatory Status

RX

2004
14 May
RX Application: 21433

Drug Name

FLOVENT HFA

Product Number

1

Dosage Form

-

Strength

0.22MG/INH

Approval Date

2004-05-14

21433 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

21433

Product Number

1

Dosage Form

-

Strength

0.22MG/INH

Approval Date

2004-05-14

Regulatory Status

RX

2004
14 May
RX Application: 21433

Drug Name

FLOVENT HFA

Product Number

2

Dosage Form

-

Strength

0.11MG/INH

Approval Date

2004-05-14

21433 / 2

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

21433

Product Number

2

Dosage Form

-

Strength

0.11MG/INH

Approval Date

2004-05-14

Regulatory Status

RX

2004
14 May
RX Application: 21433

Drug Name

FLOVENT HFA

Product Number

3

Dosage Form

-

Strength

0.044MG/INH

Approval Date

2004-05-14

21433 / 3

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

21433

Product Number

3

Dosage Form

-

Strength

0.044MG/INH

Approval Date

2004-05-14

Regulatory Status

RX

1995
01 Jun
RX Application: 20132

Drug Name

IMITREX

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1995-06-01

20132 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20132

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1995-06-01

Regulatory Status

RX

1995
01 Jun
RX Application: 20132

Drug Name

IMITREX

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-06-01

20132 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20132

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1995-06-01

Regulatory Status

RX

1995
01 Jun
RX Application: 20132

Drug Name

IMITREX

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-06-01

20132 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20132

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1995-06-01

Regulatory Status

RX

1997
26 Aug
RX Application: 20626

Drug Name

IMITREX

Product Number

1

Dosage Form

-

Strength

5MG/SPRAY

Approval Date

1997-08-26

20626 / 1

Active Ingredient

SUMATRIPTAN

Application Number

20626

Product Number

1

Dosage Form

-

Strength

5MG/SPRAY

Approval Date

1997-08-26

Regulatory Status

RX

1997
26 Aug
RX Application: 20626

Drug Name

IMITREX

Product Number

3

Dosage Form

-

Strength

20MG/SPRAY

Approval Date

1997-08-26

20626 / 3

Active Ingredient

SUMATRIPTAN

Application Number

20626

Product Number

3

Dosage Form

-

Strength

20MG/SPRAY

Approval Date

1997-08-26

Regulatory Status

RX

2006
01 Feb
RX Application: 20080

Drug Name

IMITREX STATDOSE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

Approval Date

2006-02-01

20080 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20080

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

Approval Date

2006-02-01

Regulatory Status

RX

1996
23 Dec
RX Application: 20080

Drug Name

IMITREX STATDOSE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

1996-12-23

20080 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

20080

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

1996-12-23

Regulatory Status

RX

2014
30 Apr
RX Application: 205382

Drug Name

INCRUSE ELLIPTA

Product Number

1

Dosage Form

-

Strength

EQ 0.0625MG BASE/INH

Approval Date

2014-04-30

205382 / 1

Active Ingredient

UMECLIDINIUM BROMIDE

Application Number

205382

Product Number

1

Dosage Form

-

Strength

EQ 0.0625MG BASE/INH

Approval Date

2014-04-30

Regulatory Status

RX

2018
20 Jul
RX Application: 210795

Drug Name

KRINTAFEL

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-07-20

210795 / 1

Active Ingredient

TAFENOQUINE SUCCINATE

Application Number

210795

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-07-20

Regulatory Status

RX

1994
27 Dec
RX Application: 20241

Drug Name

LAMICTAL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1994-12-27

20241 / 1

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1994-12-27

Regulatory Status

RX

1994
27 Dec
RX Application: 20241

Drug Name

LAMICTAL

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1994-12-27

20241 / 2

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1994-12-27

Regulatory Status

RX

1994
27 Dec
RX Application: 20241

Drug Name

LAMICTAL

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

1994-12-27

20241 / 3

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

1994-12-27

Regulatory Status

RX

1994
27 Dec
RX Application: 20241

Drug Name

LAMICTAL

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1994-12-27

20241 / 5

Active Ingredient

LAMOTRIGINE

Application Number

20241

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1994-12-27

Regulatory Status

RX

1998
24 Aug
RX Application: 20764

Drug Name

LAMICTAL CD

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-08-24

20764 / 1

Active Ingredient

LAMOTRIGINE

Application Number

20764

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-08-24

Regulatory Status

RX

1998
24 Aug
RX Application: 20764

Drug Name

LAMICTAL CD

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-08-24

20764 / 2

Active Ingredient

LAMOTRIGINE

Application Number

20764

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-08-24

Regulatory Status

RX

2000
08 Sep
RX Application: 20764

Drug Name

LAMICTAL CD

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2000-09-08

20764 / 4

Active Ingredient

LAMOTRIGINE

Application Number

20764

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2000-09-08

Regulatory Status

RX

2009
08 May
RX Application: 22251

Drug Name

LAMICTAL ODT

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-08

22251 / 1

Active Ingredient

LAMOTRIGINE

Application Number

22251

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-08

Regulatory Status

RX

2009
08 May
RX Application: 22251

Drug Name

LAMICTAL ODT

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-08

22251 / 2

Active Ingredient

LAMOTRIGINE

Application Number

22251

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-08

Regulatory Status

RX

2009
08 May
RX Application: 22251

Drug Name

LAMICTAL ODT

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-08

22251 / 3

Active Ingredient

LAMOTRIGINE

Application Number

22251

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-08

Regulatory Status

RX

2009
08 May
RX Application: 22251

Drug Name

LAMICTAL ODT

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-05-08

22251 / 4

Active Ingredient

LAMOTRIGINE

Application Number

22251

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-05-08

Regulatory Status

RX

2009
29 May
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-29

22115 / 1

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-05-29

Regulatory Status

RX

2009
29 May
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-29

22115 / 2

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-05-29

Regulatory Status

RX

2009
29 May
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-29

22115 / 3

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-05-29

Regulatory Status

RX

2009
29 May
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-05-29

22115 / 4

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-05-29

Regulatory Status

RX

2010
14 Apr
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

2010-04-14

22115 / 5

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

5

Dosage Form

-

Strength

300MG

Approval Date

2010-04-14

Regulatory Status

RX

2011
21 Jun
RX Application: 22115

Drug Name

LAMICTAL XR

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2011-06-21

22115 / 6

Active Ingredient

LAMOTRIGINE

Application Number

22115

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2011-06-21

Regulatory Status

RX

2000
14 Jul
RX Application: 21078

Drug Name

MALARONE

Product Number

1

Dosage Form

-

Strength

250MG;100MG

Approval Date

2000-07-14

21078 / 1

Active Ingredient

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Application Number

21078

Product Number

1

Dosage Form

-

Strength

250MG;100MG

Approval Date

2000-07-14

Regulatory Status

RX

2000
14 Jul
RX Application: 21078

Drug Name

MALARONE PEDIATRIC

Product Number

2

Dosage Form

-

Strength

62.5MG;25MG

Approval Date

2000-07-14

21078 / 2

Active Ingredient

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Application Number

21078

Product Number

2

Dosage Form

-

Strength

62.5MG;25MG

Approval Date

2000-07-14

Regulatory Status

RX

1995
08 Feb
RX Application: 20500

Drug Name

MEPRON

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

1995-02-08

20500 / 1

Active Ingredient

ATOVAQUONE

Application Number

20500

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

1995-02-08

Regulatory Status

RX

2023
15 Sep
RX Application: 216873

Drug Name

OJJAARA

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-09-15

216873 / 1

Active Ingredient

MOMELOTINIB DIHYDROCHLORIDE

Application Number

216873

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-09-15

Regulatory Status

RX

2023
15 Sep
RX Application: 216873

Drug Name

OJJAARA

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-09-15

216873 / 2

Active Ingredient

MOMELOTINIB DIHYDROCHLORIDE

Application Number

216873

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-09-15

Regulatory Status

RX

2023
15 Sep
RX Application: 216873

Drug Name

OJJAARA

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-09-15

216873 / 3

Active Ingredient

MOMELOTINIB DIHYDROCHLORIDE

Application Number

216873

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-09-15

Regulatory Status

RX

1999
26 Jul
RX Application: 21036

Drug Name

RELENZA

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1999-07-26

21036 / 1

Active Ingredient

ZANAMIVIR

Application Number

21036

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1999-07-26

Regulatory Status

RX

1997
19 Sep
RX Application: 20692

Drug Name

SEREVENT

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/INH

Approval Date

1997-09-19

20692 / 1

Active Ingredient

SALMETEROL XINAFOATE

Application Number

20692

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/INH

Approval Date

1997-09-19

Regulatory Status

RX

2017
18 Sep
RX Application: 209482

Drug Name

TRELEGY ELLIPTA

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2017-09-18

209482 / 1

Active Ingredient

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Application Number

209482

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2017-09-18

Regulatory Status

RX

2020
09 Sep
RX Application: 209482

Drug Name

TRELEGY ELLIPTA

Product Number

2

Dosage Form

-

Strength

0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2020-09-09

209482 / 2

Active Ingredient

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Application Number

209482

Product Number

2

Dosage Form

-

Strength

0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval Date

2020-09-09

Regulatory Status

RX

2026
17 Jun
RX Application: 215960

Drug Name

UTEBZI

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2026-06-17

215960 / 1

Active Ingredient

TEBIPENEM PIVOXIL HYDROBROMIDE

Application Number

215960

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2026-06-17

Regulatory Status

RX

1995
23 Jun
RX Application: 20487

Drug Name

VALTREX

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-06-23

20487 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

20487

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1995-06-23

Regulatory Status

RX

1995
23 Jun
RX Application: 20487

Drug Name

VALTREX

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1995-06-23

20487 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

20487

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1995-06-23

Regulatory Status

RX

2001
19 Apr
RX Application: 20983

Drug Name

VENTOLIN HFA

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2001-04-19

20983 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

20983

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2001-04-19

Regulatory Status

RX

1996
04 Oct
RX Application: 20358

Drug Name

WELLBUTRIN SR

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-10-04

20358 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20358

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-10-04

Regulatory Status

RX

1996
04 Oct
RX Application: 20358

Drug Name

WELLBUTRIN SR

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1996-10-04

20358 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20358

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

1996-10-04

Regulatory Status

RX

2002
14 Jun
RX Application: 20358

Drug Name

WELLBUTRIN SR

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2002-06-14

20358 / 4

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

20358

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2002-06-14

Regulatory Status

RX

2023
26 Apr
RX Application: 214876

Drug Name

ZEJULA

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-04-26

214876 / 1

Active Ingredient

NIRAPARIB TOSYLATE

Application Number

214876

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2023-04-26

Regulatory Status

RX

2023
26 Apr
RX Application: 214876

Drug Name

ZEJULA

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-04-26

214876 / 2

Active Ingredient

NIRAPARIB TOSYLATE

Application Number

214876

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-04-26

Regulatory Status

RX

2023
26 Apr
RX Application: 214876

Drug Name

ZEJULA

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2023-04-26

214876 / 3

Active Ingredient

NIRAPARIB TOSYLATE

Application Number

214876

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2023-04-26

Regulatory Status

RX

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Drug Status Breakdown
67 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

ADVAIR DISKUS 100/50

Application Number

21077

Product Number

1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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