AstraZeneca RX
FDA Approved Drugs

AstraZeneca 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 53
  • Latest Approval Date May 15, 2026
  • Data Source FDA
  • First Approval Date Aug 08, 2000
All
185
View
Unclassified
15
View
Discontinued
114
View
OTC
3
View
RX
53
View
Company Overview

Company

AstraZeneca RX

Country

United Kingdom

Website

Visit Website

Email

Russell.Gantt@astrazeneca.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

AstraZeneca RX

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Approved Drug Records ( 53 records )
2023
10 Jan
RX Application: 214070

Drug Name

AIRSUPRA

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH;0.08MG/INH

Approval Date

2023-01-10

214070 / 1

Active Ingredient

ALBUTEROL SULFATE; BUDESONIDE

Application Number

214070

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH;0.08MG/INH

Approval Date

2023-01-10

Regulatory Status

RX

2026
15 May
RX Application: 219878

Drug Name

BAXFENDY

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2026-05-15

219878 / 1

Active Ingredient

BAXDROSTAT

Application Number

219878

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2026-05-15

Regulatory Status

RX

2026
15 May
RX Application: 219878

Drug Name

BAXFENDY

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2026-05-15

219878 / 2

Active Ingredient

BAXDROSTAT

Application Number

219878

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2026-05-15

Regulatory Status

RX

2016
25 Apr
RX Application: 208294

Drug Name

BEVESPI AEROSPHERE

Product Number

1

Dosage Form

-

Strength

0.0048MG/INH;0.0090MG/INH

Approval Date

2016-04-25

208294 / 1

Active Ingredient

FORMOTEROL FUMARATE; GLYCOPYRROLATE

Application Number

208294

Product Number

1

Dosage Form

-

Strength

0.0048MG/INH;0.0090MG/INH

Approval Date

2016-04-25

Regulatory Status

RX

2020
23 Jul
RX Application: 212122

Drug Name

BREZTRI AEROSPHERE

Product Number

1

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH;0.009MG/INH

Approval Date

2020-07-23

212122 / 1

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Application Number

212122

Product Number

1

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH;0.009MG/INH

Approval Date

2020-07-23

Regulatory Status

RX

2026
27 Apr
RX Application: 212122

Drug Name

BREZTRI AEROSPHERE

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH;0.018MG/INH

Approval Date

2026-04-27

212122 / 2

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Application Number

212122

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH;0.018MG/INH

Approval Date

2026-04-27

Regulatory Status

RX

2011
20 Jul
RX Application: 22433

Drug Name

BRILINTA

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2011-07-20

22433 / 1

Active Ingredient

TICAGRELOR

Application Number

22433

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2011-07-20

Regulatory Status

RX

2015
03 Sep
RX Application: 22433

Drug Name

BRILINTA

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2015-09-03

22433 / 2

Active Ingredient

TICAGRELOR

Application Number

22433

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2015-09-03

Regulatory Status

RX

2017
31 Oct
RX Application: 210259

Drug Name

CALQUENCE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-10-31

210259 / 1

Active Ingredient

ACALABRUTINIB

Application Number

210259

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-10-31

Regulatory Status

RX

2022
03 Aug
RX Application: 216387

Drug Name

CALQUENCE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-08-03

216387 / 1

Active Ingredient

ACALABRUTINIB MALEATE

Application Number

216387

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-08-03

Regulatory Status

RX

2003
12 Aug
RX Application: 21366

Drug Name

CRESTOR

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2003-08-12

21366 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

21366

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2003-08-12

Regulatory Status

RX

2003
12 Aug
RX Application: 21366

Drug Name

CRESTOR

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-08-12

21366 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

21366

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-08-12

Regulatory Status

RX

2003
12 Aug
RX Application: 21366

Drug Name

CRESTOR

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-08-12

21366 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

21366

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-08-12

Regulatory Status

RX

2003
12 Aug
RX Application: 21366

Drug Name

CRESTOR

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-08-12

21366 / 5

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

21366

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-08-12

Regulatory Status

RX

2011
28 Feb
RX Application: 22522

Drug Name

DALIRESP

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2011-02-28

22522 / 1

Active Ingredient

ROFLUMILAST

Application Number

22522

Product Number

1

Dosage Form

-

Strength

500MCG

Approval Date

2011-02-28

Regulatory Status

RX

2018
23 Jan
RX Application: 22522

Drug Name

DALIRESP

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2018-01-23

22522 / 2

Active Ingredient

ROFLUMILAST

Application Number

22522

Product Number

2

Dosage Form

-

Strength

250MCG

Approval Date

2018-01-23

Regulatory Status

RX

2014
08 Jan
RX Application: 202293

Drug Name

FARXIGA

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-01-08

202293 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

202293

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-01-08

Regulatory Status

RX

2014
08 Jan
RX Application: 202293

Drug Name

FARXIGA

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-01-08

202293 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

202293

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-01-08

Regulatory Status

RX

2002
25 Apr
RX Application: 21344

Drug Name

FASLODEX

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2002-04-25

21344 / 1

Active Ingredient

FULVESTRANT

Application Number

21344

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2002-04-25

Regulatory Status

RX

2015
13 Jul
RX Application: 206995

Drug Name

IRESSA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-07-13

206995 / 1

Active Ingredient

GEFITINIB

Application Number

206995

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2015-07-13

Regulatory Status

RX

2020
10 Apr
RX Application: 213756

Drug Name

KOSELUGO

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-04-10

213756 / 1

Active Ingredient

SELUMETINIB SULFATE

Application Number

213756

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-04-10

Regulatory Status

RX

2020
10 Apr
RX Application: 213756

Drug Name

KOSELUGO

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-04-10

213756 / 2

Active Ingredient

SELUMETINIB SULFATE

Application Number

213756

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-04-10

Regulatory Status

RX

2025
10 Sep
RX Application: 219943

Drug Name

KOSELUGO

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-09-10

219943 / 1

Active Ingredient

SELUMETINIB SULFATE

Application Number

219943

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-09-10

Regulatory Status

RX

2025
10 Sep
RX Application: 219943

Drug Name

KOSELUGO

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2025-09-10

219943 / 2

Active Ingredient

SELUMETINIB SULFATE

Application Number

219943

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2025-09-10

Regulatory Status

RX

2018
18 May
RX Application: 207078

Drug Name

LOKELMA

Product Number

1

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2018-05-18

207078 / 1

Active Ingredient

SODIUM ZIRCONIUM CYCLOSILICATE

Application Number

207078

Product Number

1

Dosage Form

-

Strength

5GM/PACKET

Approval Date

2018-05-18

Regulatory Status

RX

2018
18 May
RX Application: 207078

Drug Name

LOKELMA

Product Number

2

Dosage Form

-

Strength

10GM/PACKET

Approval Date

2018-05-18

207078 / 2

Active Ingredient

SODIUM ZIRCONIUM CYCLOSILICATE

Application Number

207078

Product Number

2

Dosage Form

-

Strength

10GM/PACKET

Approval Date

2018-05-18

Regulatory Status

RX

2017
17 Aug
RX Application: 208558

Drug Name

LYNPARZA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-08-17

208558 / 1

Active Ingredient

OLAPARIB

Application Number

208558

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-08-17

Regulatory Status

RX

2017
17 Aug
RX Application: 208558

Drug Name

LYNPARZA

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2017-08-17

208558 / 2

Active Ingredient

OLAPARIB

Application Number

208558

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2017-08-17

Regulatory Status

RX

2001
20 Feb
RX Application: 21153

Drug Name

NEXIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2001-02-20

21153 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21153

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2001-02-20

Regulatory Status

RX

2001
20 Feb
RX Application: 21153

Drug Name

NEXIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2001-02-20

21153 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21153

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2001-02-20

Regulatory Status

RX

2006
20 Oct
RX Application: 21957

Drug Name

NEXIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2006-10-20

21957 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21957

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2006-10-20

Regulatory Status

RX

2006
20 Oct
RX Application: 21957

Drug Name

NEXIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2006-10-20

21957 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21957

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2006-10-20

Regulatory Status

RX

2011
15 Dec
RX Application: 21957

Drug Name

NEXIUM

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2011-12-15

21957 / 3

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21957

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2011-12-15

Regulatory Status

RX

2011
15 Dec
RX Application: 21957

Drug Name

NEXIUM

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2011-12-15

21957 / 4

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

21957

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2011-12-15

Regulatory Status

RX

2008
27 Feb
RX Application: 22101

Drug Name

NEXIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2008-02-27

22101 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

22101

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2008-02-27

Regulatory Status

RX

2000
08 Aug
RX Application: 20929

Drug Name

PULMICORT RESPULES

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2000-08-08

20929 / 1

Active Ingredient

BUDESONIDE

Application Number

20929

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2000-08-08

Regulatory Status

RX

2000
08 Aug
RX Application: 20929

Drug Name

PULMICORT RESPULES

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2000-08-08

20929 / 2

Active Ingredient

BUDESONIDE

Application Number

20929

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2000-08-08

Regulatory Status

RX

2000
08 Aug
RX Application: 20929

Drug Name

PULMICORT RESPULES

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2000-08-08

20929 / 3

Active Ingredient

BUDESONIDE

Application Number

20929

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2000-08-08

Regulatory Status

RX

2006
21 Jul
RX Application: 21929

Drug Name

SYMBICORT

Product Number

1

Dosage Form

-

Strength

0.08MG/INH;0.0045MG/INH

Approval Date

2006-07-21

21929 / 1

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Application Number

21929

Product Number

1

Dosage Form

-

Strength

0.08MG/INH;0.0045MG/INH

Approval Date

2006-07-21

Regulatory Status

RX

2006
21 Jul
RX Application: 21929

Drug Name

SYMBICORT

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0045MG/INH

Approval Date

2006-07-21

21929 / 2

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Application Number

21929

Product Number

2

Dosage Form

-

Strength

0.16MG/INH;0.0045MG/INH

Approval Date

2006-07-21

Regulatory Status

RX

2023
28 Apr
RX Application: 216579

Drug Name

SYMBICORT AEROSPHERE

Product Number

1

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH

Approval Date

2023-04-28

216579 / 1

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE

Application Number

216579

Product Number

1

Dosage Form

-

Strength

0.16MG/INH;0.0048MG/INH

Approval Date

2023-04-28

Regulatory Status

RX

2026
27 Apr
RX Application: 216579

Drug Name

SYMBICORT AEROSPHERE

Product Number

2

Dosage Form

-

Strength

0.08MG/INH;0.0048MG/INH

Approval Date

2026-04-27

216579 / 2

Active Ingredient

BUDESONIDE; FORMOTEROL FUMARATE

Application Number

216579

Product Number

2

Dosage Form

-

Strength

0.08MG/INH;0.0048MG/INH

Approval Date

2026-04-27

Regulatory Status

RX

2015
13 Nov
RX Application: 208065

Drug Name

TAGRISSO

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-11-13

208065 / 1

Active Ingredient

OSIMERTINIB MESYLATE

Application Number

208065

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-11-13

Regulatory Status

RX

2015
13 Nov
RX Application: 208065

Drug Name

TAGRISSO

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2015-11-13

208065 / 2

Active Ingredient

OSIMERTINIB MESYLATE

Application Number

208065

Product Number

2

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2015-11-13

Regulatory Status

RX

2023
16 Nov
RX Application: 218197

Drug Name

TRUQAP

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

2023-11-16

218197 / 1

Active Ingredient

CAPIVASERTIB

Application Number

218197

Product Number

1

Dosage Form

-

Strength

160MG

Approval Date

2023-11-16

Regulatory Status

RX

2023
16 Nov
RX Application: 218197

Drug Name

TRUQAP

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2023-11-16

218197 / 2

Active Ingredient

CAPIVASERTIB

Application Number

218197

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2023-11-16

Regulatory Status

RX

2026
15 Apr
RX Application: 217388

Drug Name

WAINUA

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

Approval Date

2026-04-15

217388 / 2

Active Ingredient

EPLONTERSEN SODIUM

Application Number

217388

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

Approval Date

2026-04-15

Regulatory Status

RX

2023
21 Dec
RX Application: 217388

Drug Name

WAINUA (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

Approval Date

2023-12-21

217388 / 1

Active Ingredient

EPLONTERSEN SODIUM

Application Number

217388

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

Approval Date

2023-12-21

Regulatory Status

RX

2014
29 Oct
RX Application: 205649

Drug Name

XIGDUO XR

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2014-10-29

205649 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205649

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2014-10-29

Regulatory Status

RX

2014
29 Oct
RX Application: 205649

Drug Name

XIGDUO XR

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2014-10-29

205649 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205649

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2014-10-29

Regulatory Status

RX

2014
29 Oct
RX Application: 205649

Drug Name

XIGDUO XR

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2014-10-29

205649 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205649

Product Number

3

Dosage Form

-

Strength

10MG;500MG

Approval Date

2014-10-29

Regulatory Status

RX

2014
29 Oct
RX Application: 205649

Drug Name

XIGDUO XR

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2014-10-29

205649 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205649

Product Number

4

Dosage Form

-

Strength

10MG;1GM

Approval Date

2014-10-29

Regulatory Status

RX

2017
28 Jul
RX Application: 205649

Drug Name

XIGDUO XR

Product Number

5

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2017-07-28

205649 / 5

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205649

Product Number

5

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2017-07-28

Regulatory Status

RX

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Drug Status Breakdown
53 total
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

AIRSUPRA

Application Number

214070

Product Number

1

Active Ingredient

ALBUTEROL SULFATE; BUDESONIDE

Dosage Form

-

Strength

EQ 0.09MG BASE/INH;0.08MG/INH

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