AstraZeneca Discontinued
FDA Approved Drugs

AstraZeneca Discontinued

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.

Discontinued
  • Total Records 114
  • Latest Approval Date May 02, 2019
  • 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 Discontinued

Country

United Kingdom

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Company Snapshot

AstraZeneca Discontinued

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Approved Drug Records ( 114 records )
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
114 total
  • Discontinued
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

AQUASOL A

Application Number

83080

Product Number

1

Active Ingredient

VITAMIN A

Dosage Form

-

Strength

50,000USP UNITS

FDA Approved Drug Data

Approved drug product information

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