AstraZeneca
FDA Approved Drugs

AstraZeneca

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 Discontinued Unclassified OTC
  • Total Records 185
  • Latest Approval Date May 15, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
185
View
Unclassified
15
View
Discontinued
114
View
OTC
3
View
RX
53
View
Company Overview

Company

AstraZeneca

Country

United Kingdom

Website

Visit Website

Email

Russell.Gantt@astrazeneca.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

AstraZeneca

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Approved Drug Records ( 185 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

1982
01 Jan
Discontinued Application: 83080

Drug Name

AQUASOL A

Product Number

1

Dosage Form

-

Strength

50,000USP UNITS

Approval Date

1982-01-01

83080 / 1

Active Ingredient

VITAMIN A

Application Number

83080

Product Number

1

Dosage Form

-

Strength

50,000USP UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83080

Drug Name

AQUASOL A

Product Number

2

Dosage Form

-

Strength

25,000USP UNITS

Approval Date

1982-01-01

83080 / 2

Active Ingredient

VITAMIN A

Application Number

83080

Product Number

2

Dosage Form

-

Strength

25,000USP UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 22214

Drug Name

ARIMIDEX

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

22214 / 1

Active Ingredient

ANASTROZOLE

Application Number

22214

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

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

-
Unclassified Application: 761328

Drug Name

BEYFORTUS

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

761328 / 1

Active Ingredient

NIRSEVIMAB-ALIP

Application Number

761328

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761328

Drug Name

BEYFORTUS

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

761328 / 2

Active Ingredient

NIRSEVIMAB-ALIP

Application Number

761328

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

1987
10 Aug
Discontinued Application: 71151

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

71151 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

71151

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

Regulatory Status

Discontinued

1987
10 Aug
Discontinued Application: 71152

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

71152 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

71152

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

Regulatory Status

Discontinued

1987
10 Aug
Discontinued Application: 71153

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

71153 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

71153

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-08-10

Regulatory Status

Discontinued

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

2012
27 Jan
Discontinued Application: 22200

Drug Name

BYDUREON

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

2012-01-27

22200 / 1

Active Ingredient

EXENATIDE SYNTHETIC

Application Number

22200

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

2012-01-27

Regulatory Status

Discontinued

2017
20 Oct
Discontinued Application: 209210

Drug Name

BYDUREON BCISE

Product Number

1

Dosage Form

-

Strength

2MG/0.85ML (2MG/0.85ML)

Approval Date

2017-10-20

209210 / 1

Active Ingredient

EXENATIDE SYNTHETIC

Application Number

209210

Product Number

1

Dosage Form

-

Strength

2MG/0.85ML (2MG/0.85ML)

Approval Date

2017-10-20

Regulatory Status

Discontinued

2014
28 Feb
Discontinued Application: 22200

Drug Name

BYDUREON PEN

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2014-02-28

22200 / 2

Active Ingredient

EXENATIDE SYNTHETIC

Application Number

22200

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2014-02-28

Regulatory Status

Discontinued

2005
28 Apr
Discontinued Application: 21773

Drug Name

BYETTA

Product Number

1

Dosage Form

-

Strength

300MCG/1.2ML (250MCG/ML)

Approval Date

2005-04-28

21773 / 1

Active Ingredient

EXENATIDE SYNTHETIC

Application Number

21773

Product Number

1

Dosage Form

-

Strength

300MCG/1.2ML (250MCG/ML)

Approval Date

2005-04-28

Regulatory Status

Discontinued

2005
28 Apr
Discontinued Application: 21773

Drug Name

BYETTA

Product Number

2

Dosage Form

-

Strength

600MCG/2.4ML (250MCG/ML)

Approval Date

2005-04-28

21773 / 2

Active Ingredient

EXENATIDE SYNTHETIC

Application Number

21773

Product Number

2

Dosage Form

-

Strength

600MCG/2.4ML (250MCG/ML)

Approval Date

2005-04-28

Regulatory Status

Discontinued

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

-
Unclassified Application: 22310

Drug Name

CASODEX

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

22310 / 1

Active Ingredient

BICALUTAMIDE

Application Number

22310

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 14763

Drug Name

CITANEST

Product Number

3

Dosage Form

-

Strength

3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14763 / 3

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

14763

Product Number

3

Dosage Form

-

Strength

3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14763

Drug Name

CITANEST

Product Number

4

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14763 / 4

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

14763

Product Number

4

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14763

Drug Name

CITANEST

Product Number

5

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14763 / 5

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

14763

Product Number

5

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14763

Drug Name

CITANEST FORTE

Product Number

8

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

1982-01-01

14763 / 8

Active Ingredient

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Application Number

14763

Product Number

8

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14763

Drug Name

CITANEST PLAIN

Product Number

7

Dosage Form

-

Strength

4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

14763 / 7

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

14763

Product Number

7

Dosage Form

-

Strength

4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

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

1989
29 Dec
Discontinued Application: 19082

Drug Name

DALGAN

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1989-12-29

19082 / 1

Active Ingredient

DEZOCINE

Application Number

19082

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 19082

Drug Name

DALGAN

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1989-12-29

19082 / 2

Active Ingredient

DEZOCINE

Application Number

19082

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 19082

Drug Name

DALGAN

Product Number

3

Dosage Form

-

Strength

15MG/ML

Approval Date

1989-12-29

19082 / 3

Active Ingredient

DEZOCINE

Application Number

19082

Product Number

3

Dosage Form

-

Strength

15MG/ML

Approval Date

1989-12-29

Regulatory Status

Discontinued

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

1988
20 Oct
Discontinued Application: 72018

Drug Name

DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-10-20

72018 / 1

Active Ingredient

DROPERIDOL

Application Number

72018

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-10-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17751

Drug Name

DURANEST

Product Number

3

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17751 / 3

Active Ingredient

ETIDOCAINE HYDROCHLORIDE

Application Number

17751

Product Number

3

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17751

Drug Name

DURANEST

Product Number

4

Dosage Form

-

Strength

0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17751 / 4

Active Ingredient

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE

Application Number

17751

Product Number

4

Dosage Form

-

Strength

0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17751

Drug Name

DURANEST

Product Number

5

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17751 / 5

Active Ingredient

ETIDOCAINE HYDROCHLORIDE

Application Number

17751

Product Number

5

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17751

Drug Name

DURANEST

Product Number

6

Dosage Form

-

Strength

0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17751 / 6

Active Ingredient

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

Application Number

17751

Product Number

6

Dosage Form

-

Strength

0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17751

Drug Name

DURANEST

Product Number

7

Dosage Form

-

Strength

0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17751 / 7

Active Ingredient

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

Application Number

17751

Product Number

7

Dosage Form

-

Strength

0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9925

Drug Name

DYCLONE

Product Number

1

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9925 / 1

Active Ingredient

DYCLONINE HYDROCHLORIDE

Application Number

9925

Product Number

1

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9925

Drug Name

DYCLONE

Product Number

2

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9925 / 2

Active Ingredient

DYCLONINE HYDROCHLORIDE

Application Number

9925

Product Number

2

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

1

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

3

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

3

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

4

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

4

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

5

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

5

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

6

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 6

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

6

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12703

Drug Name

ELAVIL

Product Number

7

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12703 / 7

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12703

Product Number

7

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12704

Drug Name

ELAVIL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

12704 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

12704

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
04 Feb
Discontinued Application: 20962

Drug Name

EMLA

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

1998-02-04

20962 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

20962

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

1998-02-04

Regulatory Status

Discontinued

2014
05 May
Discontinued Application: 205060

Drug Name

EPANOVA

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS

Approval Date

2014-05-05

205060 / 1

Active Ingredient

OMEGA-3-CARBOXYLIC ACIDS

Application Number

205060

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS

Approval Date

2014-05-05

Regulatory Status

Discontinued

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

-
Unclassified Application: 761070

Drug Name

FASENRA

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

-

761070 / 1

Active Ingredient

BENRALIZUMAB

Application Number

761070

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

-

Regulatory Status

Unclassified

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

2002
25 Apr
Discontinued Application: 21344

Drug Name

FASLODEX

Product Number

2

Dosage Form

-

Strength

125MG/2.5ML (50MG/ML)

Approval Date

2002-04-25

21344 / 2

Active Ingredient

FULVESTRANT

Application Number

21344

Product Number

2

Dosage Form

-

Strength

125MG/2.5ML (50MG/ML)

Approval Date

2002-04-25

Regulatory Status

Discontinued

1989
13 Apr
Discontinued Application: 72026

Drug Name

FENTANYL CITRATE AND DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

72026 / 1

Active Ingredient

DROPERIDOL; FENTANYL CITRATE

Application Number

72026

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

Regulatory Status

Discontinued

1989
13 Apr
Discontinued Application: 72027

Drug Name

FENTANYL CITRATE AND DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

72027 / 1

Active Ingredient

DROPERIDOL; FENTANYL CITRATE

Application Number

72027

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

Regulatory Status

Discontinued

1989
13 Apr
Discontinued Application: 72028

Drug Name

FENTANYL CITRATE AND DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

72028 / 1

Active Ingredient

DROPERIDOL; FENTANYL CITRATE

Application Number

72028

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1989-04-13

Regulatory Status

Discontinued

1985
09 Sep
Discontinued Application: 70014

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1985-09-09

70014 / 1

Active Ingredient

FUROSEMIDE

Application Number

70014

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1985-09-09

Regulatory Status

Discontinued

-
Unclassified Application: 761270

Drug Name

IMJUDO

Product Number

1

Dosage Form

-

Strength

25MG/1.25ML(20MG/ML)

Approval Date

-

761270 / 1

Active Ingredient

TREMELIMUMAB-ACTL

Application Number

761270

Product Number

1

Dosage Form

-

Strength

25MG/1.25ML(20MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761270

Drug Name

IMJUDO

Product Number

2

Dosage Form

-

Strength

300MG/15ML(20MG/ML)

Approval Date

-

761270 / 2

Active Ingredient

TREMELIMUMAB-ACTL

Application Number

761270

Product Number

2

Dosage Form

-

Strength

300MG/15ML(20MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761289

Drug Name

IMJUDO

Product Number

1

Dosage Form

-

Strength

25MG/1.25ML(20MG/ML)

Approval Date

-

761289 / 1

Active Ingredient

TREMELIMUMAB-ACTL

Application Number

761289

Product Number

1

Dosage Form

-

Strength

25MG/1.25ML(20MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761289

Drug Name

IMJUDO

Product Number

2

Dosage Form

-

Strength

300MG/15ML(20MG/ML)

Approval Date

-

761289 / 2

Active Ingredient

TREMELIMUMAB-ACTL

Application Number

761289

Product Number

2

Dosage Form

-

Strength

300MG/15ML(20MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2003
05 May
Discontinued Application: 21399

Drug Name

IRESSA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-05-05

21399 / 1

Active Ingredient

GEFITINIB

Application Number

21399

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-05-05

Regulatory Status

Discontinued

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

1982
15 Nov
Discontinued Application: 87937

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.062%

Approval Date

1982-11-15

87937 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

87937

Product Number

1

Dosage Form

-

Strength

0.062%

Approval Date

1982-11-15

Regulatory Status

Discontinued

1982
15 Nov
Discontinued Application: 87938

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1982-11-15

87938 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

87938

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1982-11-15

Regulatory Status

Discontinued

1984
14 Mar
Discontinued Application: 88470

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1984-03-14

88470 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88470

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1984-03-14

Regulatory Status

Discontinued

1984
14 Mar
Discontinued Application: 88471

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1984-03-14

88471 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88471

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1984-03-14

Regulatory Status

Discontinued

1984
14 Mar
Discontinued Application: 88472

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1984-03-14

88472 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

88472

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1984-03-14

Regulatory Status

Discontinued

1991
13 Jun
Discontinued Application: 89614

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.062%

Approval Date

1991-06-13

89614 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

89614

Product Number

1

Dosage Form

-

Strength

0.062%

Approval Date

1991-06-13

Regulatory Status

Discontinued

1991
13 Jun
Discontinued Application: 89615

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1991-06-13

89615 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

89615

Product Number

1

Dosage Form

-

Strength

0.125%

Approval Date

1991-06-13

Regulatory Status

Discontinued

1991
13 Jun
Discontinued Application: 89616

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1991-06-13

89616 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

89616

Product Number

1

Dosage Form

-

Strength

0.167%

Approval Date

1991-06-13

Regulatory Status

Discontinued

1991
13 Jun
Discontinued Application: 89617

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1991-06-13

89617 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

89617

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1991-06-13

Regulatory Status

Discontinued

1991
13 Jun
Discontinued Application: 89618

Drug Name

ISOETHARINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1991-06-13

89618 / 1

Active Ingredient

ISOETHARINE HYDROCHLORIDE

Application Number

89618

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1991-06-13

Regulatory Status

Discontinued

2010
05 Nov
Discontinued Application: 200678

Drug Name

KOMBIGLYZE XR

Product Number

1

Dosage Form

-

Strength

500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

200678 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

200678

Product Number

1

Dosage Form

-

Strength

500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

Regulatory Status

Discontinued

2010
05 Nov
Discontinued Application: 200678

Drug Name

KOMBIGLYZE XR

Product Number

2

Dosage Form

-

Strength

1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

200678 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

200678

Product Number

2

Dosage Form

-

Strength

1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

Regulatory Status

Discontinued

2010
05 Nov
Discontinued Application: 200678

Drug Name

KOMBIGLYZE XR

Product Number

3

Dosage Form

-

Strength

1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

200678 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

200678

Product Number

3

Dosage Form

-

Strength

1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-05

Regulatory Status

Discontinued

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

-
Unclassified Application: 219943

Drug Name

KOSELUGO

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

219943 / 3

Active Ingredient

SELUMETINIB

Application Number

219943

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219943

Drug Name

KOSELUGO

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

-

219943 / 4

Active Ingredient

SELUMETINIB

Application Number

219943

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

1996
27 Dec
Discontinued Application: 20668

Drug Name

LEXXEL

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

1996-12-27

20668 / 1

Active Ingredient

ENALAPRIL MALEATE; FELODIPINE

Application Number

20668

Product Number

1

Dosage Form

-

Strength

5MG;5MG

Approval Date

1996-12-27

Regulatory Status

Discontinued

1998
28 Oct
Discontinued Application: 20668

Drug Name

LEXXEL

Product Number

2

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

1998-10-28

20668 / 2

Active Ingredient

ENALAPRIL MALEATE; FELODIPINE

Application Number

20668

Product Number

2

Dosage Form

-

Strength

5MG;2.5MG

Approval Date

1998-10-28

Regulatory Status

Discontinued

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

2014
19 Dec
Discontinued Application: 206162

Drug Name

LYNPARZA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-12-19

206162 / 1

Active Ingredient

OLAPARIB

Application Number

206162

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-12-19

Regulatory Status

Discontinued

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

1988
27 Jul
Discontinued Application: 71018

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1988-07-27

71018 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

71018

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1988-07-27

Regulatory Status

Discontinued

1988
27 Jul
Discontinued Application: 71275

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

1988-07-27

71275 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

71275

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

1988-07-27

Regulatory Status

Discontinued

1989
11 Apr
Discontinued Application: 72081

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1989-04-11

72081 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

72081

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1989-04-11

Regulatory Status

Discontinued

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

2014
28 Mar
OTC Application: 204655

Drug Name

NEXIUM 24HR

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-03-28

204655 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

204655

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-03-28

Regulatory Status

OTC

2015
23 Nov
OTC Application: 207920

Drug Name

NEXIUM 24HR

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-23

207920 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

207920

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-23

Regulatory Status

OTC

2005
31 Mar
Discontinued Application: 21689

Drug Name

NEXIUM IV

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-03-31

21689 / 1

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

21689

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-03-31

Regulatory Status

Discontinued

2005
31 Mar
Discontinued Application: 21689

Drug Name

NEXIUM IV

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-03-31

21689 / 2

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

21689

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-03-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17970

Drug Name

NOLVADEX

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17970 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

17970

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
21 Mar
Discontinued Application: 17970

Drug Name

NOLVADEX

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-21

17970 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

17970

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-03-21

Regulatory Status

Discontinued

2009
31 Jul
Discontinued Application: 22350

Drug Name

ONGLYZA

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-31

22350 / 1

Active Ingredient

SAXAGLIPTIN HYDROCHLORIDE

Application Number

22350

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-31

Regulatory Status

Discontinued

2009
31 Jul
Discontinued Application: 22350

Drug Name

ONGLYZA

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-31

22350 / 2

Active Ingredient

SAXAGLIPTIN HYDROCHLORIDE

Application Number

22350

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-31

Regulatory Status

Discontinued

1991
25 Jul
Discontinued Application: 19834

Drug Name

PLENDIL

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-07-25

19834 / 1

Active Ingredient

FELODIPINE

Application Number

19834

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-07-25

Regulatory Status

Discontinued

1991
25 Jul
Discontinued Application: 19834

Drug Name

PLENDIL

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-07-25

19834 / 2

Active Ingredient

FELODIPINE

Application Number

19834

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-07-25

Regulatory Status

Discontinued

1994
22 Sep
Discontinued Application: 19834

Drug Name

PLENDIL

Product Number

4

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-09-22

19834 / 4

Active Ingredient

FELODIPINE

Application Number

19834

Product Number

4

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-09-22

Regulatory Status

Discontinued

1989
14 Sep
Discontinued Application: 19810

Drug Name

PRILOSEC

Product Number

1

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-14

19810 / 1

Active Ingredient

OMEPRAZOLE

Application Number

19810

Product Number

1

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-14

Regulatory Status

Discontinued

1998
15 Jan
Discontinued Application: 19810

Drug Name

PRILOSEC

Product Number

2

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-01-15

19810 / 2

Active Ingredient

OMEPRAZOLE

Application Number

19810

Product Number

2

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-01-15

Regulatory Status

Discontinued

1995
05 Oct
Discontinued Application: 19810

Drug Name

PRILOSEC

Product Number

3

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-05

19810 / 3

Active Ingredient

OMEPRAZOLE

Application Number

19810

Product Number

3

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-05

Regulatory Status

Discontinued

2003
20 Jun
OTC Application: 21229

Drug Name

PRILOSEC OTC

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-06-20

21229 / 1

Active Ingredient

OMEPRAZOLE MAGNESIUM

Application Number

21229

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-06-20

Regulatory Status

OTC

1997
24 Jun
Discontinued Application: 20441

Drug Name

PULMICORT

Product Number

2

Dosage Form

-

Strength

0.16MG/INH

Approval Date

1997-06-24

20441 / 2

Active Ingredient

BUDESONIDE

Application Number

20441

Product Number

2

Dosage Form

-

Strength

0.16MG/INH

Approval Date

1997-06-24

Regulatory Status

Discontinued

1997
24 Jun
Discontinued Application: 20441

Drug Name

PULMICORT

Product Number

3

Dosage Form

-

Strength

0.32MG/INH

Approval Date

1997-06-24

20441 / 3

Active Ingredient

BUDESONIDE

Application Number

20441

Product Number

3

Dosage Form

-

Strength

0.32MG/INH

Approval Date

1997-06-24

Regulatory Status

Discontinued

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

2017
27 Feb
Discontinued Application: 209091

Drug Name

QTERN

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2017-02-27

209091 / 1

Active Ingredient

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Application Number

209091

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2017-02-27

Regulatory Status

Discontinued

2019
02 May
Discontinued Application: 209091

Drug Name

QTERN

Product Number

2

Dosage Form

-

Strength

5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2019-05-02

209091 / 2

Active Ingredient

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Application Number

209091

Product Number

2

Dosage Form

-

Strength

5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2019-05-02

Regulatory Status

Discontinued

2019
02 May
Discontinued Application: 210874

Drug Name

QTERNMET XR

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM;EQ 2.5MG BASE

Approval Date

2019-05-02

210874 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

210874

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM;EQ 2.5MG BASE

Approval Date

2019-05-02

Regulatory Status

Discontinued

2019
02 May
Discontinued Application: 210874

Drug Name

QTERNMET XR

Product Number

2

Dosage Form

-

Strength

5MG;1GM;EQ 2.5MG BASE

Approval Date

2019-05-02

210874 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

210874

Product Number

2

Dosage Form

-

Strength

5MG;1GM;EQ 2.5MG BASE

Approval Date

2019-05-02

Regulatory Status

Discontinued

2019
02 May
Discontinued Application: 210874

Drug Name

QTERNMET XR

Product Number

3

Dosage Form

-

Strength

5MG;1GM;EQ 5MG BASE

Approval Date

2019-05-02

210874 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

210874

Product Number

3

Dosage Form

-

Strength

5MG;1GM;EQ 5MG BASE

Approval Date

2019-05-02

Regulatory Status

Discontinued

2019
02 May
Discontinued Application: 210874

Drug Name

QTERNMET XR

Product Number

4

Dosage Form

-

Strength

10MG;1GM;EQ 5MG BASE

Approval Date

2019-05-02

210874 / 4

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

210874

Product Number

4

Dosage Form

-

Strength

10MG;1GM;EQ 5MG BASE

Approval Date

2019-05-02

Regulatory Status

Discontinued

1994
14 Feb
Discontinued Application: 20233

Drug Name

RHINOCORT

Product Number

1

Dosage Form

-

Strength

0.032MG/INH

Approval Date

1994-02-14

20233 / 1

Active Ingredient

BUDESONIDE

Application Number

20233

Product Number

1

Dosage Form

-

Strength

0.032MG/INH

Approval Date

1994-02-14

Regulatory Status

Discontinued

-
Unclassified Application: 761123

Drug Name

SAPHNELO

Product Number

1

Dosage Form

-

Strength

300MG/2ML(150MG/ML)

Approval Date

-

761123 / 1

Active Ingredient

ANIFROLUMAB-FNIA

Application Number

761123

Product Number

1

Dosage Form

-

Strength

300MG/2ML(150MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761451

Drug Name

SAPHNELO

Product Number

1

Dosage Form

-

Strength

300MG/2ML (150MG/ML

Approval Date

-

761451 / 1

Active Ingredient

ANIFROLUMAB-FNIA

Application Number

761451

Product Number

1

Dosage Form

-

Strength

300MG/2ML (150MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761451

Drug Name

SAPHNELO

Product Number

2

Dosage Form

-

Strength

120MG/0.8ML

Approval Date

-

761451 / 2

Active Ingredient

ANIFROLUMAB-FNIA

Application Number

761451

Product Number

2

Dosage Form

-

Strength

120MG/0.8ML

Approval Date

-

Regulatory Status

Unclassified

1996
01 Apr
Discontinued Application: 16191

Drug Name

SORBITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

16191 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16191

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1996
01 Apr
Discontinued Application: 16191

Drug Name

SORBITRATE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1996-04-01

16191 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16191

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1996
01 Apr
Discontinued Application: 16192

Drug Name

SORBITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

16192 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16192

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1996
01 Apr
Discontinued Application: 16192

Drug Name

SORBITRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1996-04-01

16192 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16192

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1996
01 Apr
Discontinued Application: 16776

Drug Name

SORBITRATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

16776 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16776

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1996
01 Apr
Discontinued Application: 16776

Drug Name

SORBITRATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1996-04-01

16776 / 3

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

16776

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

1996-04-01

Regulatory Status

Discontinued

1990
21 Aug
Discontinued Application: 86405

Drug Name

SORBITRATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1990-08-21

86405 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86405

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1990-08-21

Regulatory Status

Discontinued

1990
21 Aug
Discontinued Application: 88124

Drug Name

SORBITRATE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1990-08-21

88124 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

88124

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1990-08-21

Regulatory Status

Discontinued

1990
21 Aug
Discontinued Application: 88125

Drug Name

SORBITRATE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1990-08-21

88125 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

88125

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1990-08-21

Regulatory Status

Discontinued

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

2005
16 Mar
Discontinued Application: 21332

Drug Name

SYMLIN

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)

Approval Date

2005-03-16

21332 / 1

Active Ingredient

PRAMLINTIDE ACETATE

Application Number

21332

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)

Approval Date

2005-03-16

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 21332

Drug Name

SYMLIN

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

Approval Date

2007-09-25

21332 / 2

Active Ingredient

PRAMLINTIDE ACETATE

Application Number

21332

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

Approval Date

2007-09-25

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 21332

Drug Name

SYMLIN

Product Number

3

Dosage Form

-

Strength

EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

Approval Date

2007-09-25

21332 / 3

Active Ingredient

PRAMLINTIDE ACETATE

Application Number

21332

Product Number

3

Dosage Form

-

Strength

EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

Approval Date

2007-09-25

Regulatory Status

Discontinued

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

1989
13 Sep
Discontinued Application: 19058

Drug Name

TENORMIN

Product Number

1

Dosage Form

-

Strength

0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-13

19058 / 1

Active Ingredient

ATENOLOL

Application Number

19058

Product Number

1

Dosage Form

-

Strength

0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-13

Regulatory Status

Discontinued

-
Unclassified Application: 761224

Drug Name

TEZSPIRE

Product Number

1

Dosage Form

-

Strength

210MG/1.91ML(110MG/ML)

Approval Date

-

761224 / 1

Active Ingredient

TEZEPELUMAB-EKKO

Application Number

761224

Product Number

1

Dosage Form

-

Strength

210MG/1.91ML(110MG/ML)

Approval Date

-

Regulatory Status

Unclassified

1984
09 Nov
Discontinued Application: 18257

Drug Name

TONOCARD

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1984-11-09

18257 / 1

Active Ingredient

TOCAINIDE HYDROCHLORIDE

Application Number

18257

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1984-11-09

Regulatory Status

Discontinued

1984
09 Nov
Discontinued Application: 18257

Drug Name

TONOCARD

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

1984-11-09

18257 / 2

Active Ingredient

TOCAINIDE HYDROCHLORIDE

Application Number

18257

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

1984-11-09

Regulatory Status

Discontinued

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

1982
01 Jan
Discontinued Application: 8048

Drug Name

XYLOCAINE

Product Number

1

Dosage Form

-

Strength

5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8048 / 1

Active Ingredient

LIDOCAINE

Application Number

8048

Product Number

1

Dosage Form

-

Strength

5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE

Product Number

5

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

10418 / 5

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

5

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE

Product Number

7

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

10418 / 7

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

7

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE

Product Number

9

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

10418 / 9

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

9

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13077

Drug Name

XYLOCAINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

13077 / 1

Active Ingredient

LIDOCAINE

Application Number

13077

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14127

Drug Name

XYLOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

14127 / 1

Active Ingredient

LIDOCAINE

Application Number

14127

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14394

Drug Name

XYLOCAINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

14394 / 1

Active Ingredient

LIDOCAINE

Application Number

14394

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
07 Jul
Discontinued Application: 10496

Drug Name

XYLOCAINE 5% W/ GLUCOSE 7.5%

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

1982-07-07

10496 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

10496

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

1982-07-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

6

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1982-01-01

10418 / 6

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

6

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

8

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1982-01-01

10418 / 8

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

8

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10418

Drug Name

XYLOCAINE W/ EPINEPHRINE

Product Number

10

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1982-01-01

10418 / 10

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

10418

Product Number

10

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18555

Drug Name

YUTOPAR

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

18555 / 1

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

18555

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18580

Drug Name

YUTOPAR

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

18580 / 1

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

18580

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
27 Sep
Discontinued Application: 18580

Drug Name

YUTOPAR

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

1984-09-27

18580 / 2

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

18580

Product Number

2

Dosage Form

-

Strength

15MG/ML

Approval Date

1984-09-27

Regulatory Status

Discontinued

1997
25 Nov
Discontinued Application: 20768

Drug Name

ZOMIG

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-11-25

20768 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

20768

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-11-25

Regulatory Status

Discontinued

1997
25 Nov
Discontinued Application: 20768

Drug Name

ZOMIG

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-11-25

20768 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

20768

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-11-25

Regulatory Status

Discontinued

2001
13 Feb
Discontinued Application: 21231

Drug Name

ZOMIG-ZMT

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-13

21231 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

21231

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-13

Regulatory Status

Discontinued

2001
17 Sep
Discontinued Application: 21231

Drug Name

ZOMIG-ZMT

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-17

21231 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

21231

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-09-17

Regulatory Status

Discontinued

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Drug Status Breakdown
185 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
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

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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