Eli Lilly

2009

22 May

RX Application: 22332

Drug Name

ADCIRCA

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2009-05-22

22332 / 1 View Details

Active Ingredient

TADALAFIL

Application Number

22332

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2009-05-22

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 7245

Drug Name

AEROLONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

7245 / 1 View Details

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

7245

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004

04 Feb

RX Application: 21462

Drug Name

ALIMTA

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-02-04

21462 / 1 View Details

Active Ingredient

PEMETREXED DISODIUM

Application Number

21462

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-02-04

Regulatory Status

RX

2007

07 Sep

RX Application: 21462

Drug Name

ALIMTA

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2007-09-07

21462 / 2 View Details

Active Ingredient

PEMETREXED DISODIUM

Application Number

21462

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2007-09-07

Regulatory Status

RX

-

Unclassified Application: 21677

Drug Name

ALIMTA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

21677 / 1 View Details

Active Ingredient

PEMETREXED

Application Number

21677

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 80883

Drug Name

ALPHALIN

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

80883 / 1 View Details

Active Ingredient

VITAMIN A PALMITATE

Application Number

80883

Product Number

1

Dosage Form

-

Strength

EQ 50,000 UNITS BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

04 Apr

Discontinued Application: 62565

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-04-04

62565 / 1 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

62565

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-04-04

Regulatory Status

Discontinued

1985

04 Apr

Discontinued Application: 62565

Drug Name

AMPICILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-04-04

62565 / 2 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

62565

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-04-04

Regulatory Status

Discontinued

1986

24 Jun

Discontinued Application: 62565

Drug Name

AMPICILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-06-24

62565 / 3 View Details

Active Ingredient

AMPICILLIN SODIUM

Application Number

62565

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13157

Drug Name

ANHYDRON

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

13157 / 2 View Details

Active Ingredient

CYCLOTHIAZIDE

Application Number

13157

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 14684

Drug Name

AVENTYL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

14684 / 1 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

14684

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 14684

Drug Name

AVENTYL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

14684 / 2 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

14684

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2010

23 Nov

Discontinued Application: 22504

Drug Name

AXIRON

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-23

22504 / 1 View Details

Active Ingredient

TESTOSTERONE

Application Number

22504

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-11-23

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60687

Drug Name

BACITRACIN

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1982-01-01

60687 / 1 View Details

Active Ingredient

BACITRACIN

Application Number

60687

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 205692

Drug Name

BASAGLAR

Product Number

1

Dosage Form

-

Strength

300 UNITS/3ML (100 UNITS/ML)

Approval Date

-

205692 / 1 View Details

Active Ingredient

INSULIN GLARGINE

Application Number

205692

Product Number

1

Dosage Form

-

Strength

300 UNITS/3ML (100 UNITS/ML)

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 80855

Drug Name

BETALIN 12

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1982-01-01

80855 / 1 View Details

Active Ingredient

CYANOCOBALAMIN

Application Number

80855

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80855

Drug Name

BETALIN 12

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

80855 / 2 View Details

Active Ingredient

CYANOCOBALAMIN

Application Number

80855

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80853

Drug Name

BETALIN S

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

80853 / 1 View Details

Active Ingredient

THIAMINE HYDROCHLORIDE

Application Number

80853

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6470

Drug Name

CALCIUM GLUCEPTATE

Product Number

1

Dosage Form

-

Strength

EQ 90MG CALCIUM/5ML

Approval Date

1982-01-01

6470 / 1 View Details

Active Ingredient

CALCIUM GLUCEPTATE

Application Number

6470

Product Number

1

Dosage Form

-

Strength

EQ 90MG CALCIUM/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50521

Drug Name

CECLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50521 / 1 View Details

Active Ingredient

CEFACLOR

Application Number

50521

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE **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: 50521

Drug Name

CECLOR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50521 / 2 View Details

Active Ingredient

CEFACLOR

Application Number

50521

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE **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: 50522

Drug Name

CECLOR

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50522 / 1 View Details

Active Ingredient

CEFACLOR

Application Number

50522

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML **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: 50522

Drug Name

CECLOR

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50522 / 2 View Details

Active Ingredient

CEFACLOR

Application Number

50522

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996

28 Jun

Discontinued Application: 50673

Drug Name

CECLOR CD

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-28

50673 / 1 View Details

Active Ingredient

CEFACLOR

Application Number

50673

Product Number

1

Dosage Form

-

Strength

EQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-28

Regulatory Status

Discontinued

1996

28 Jun

Discontinued Application: 50673

Drug Name

CECLOR CD

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-06-28

50673 / 2 View Details

Active Ingredient

CEFACLOR

Application Number

50673

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-06-28

Regulatory Status

Discontinued

2003

21 Nov

RX Application: 21368

Drug Name

CIALIS

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-11-21

21368 / 1 View Details

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-11-21

Regulatory Status

RX

2003

21 Nov

RX Application: 21368

Drug Name

CIALIS

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-11-21

21368 / 2 View Details

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-11-21

Regulatory Status

RX

2003

21 Nov

RX Application: 21368

Drug Name

CIALIS

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-11-21

21368 / 3 View Details

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-11-21

Regulatory Status

RX

2008

07 Jan

Discontinued Application: 21368

Drug Name

CIALIS

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

2008-01-07

21368 / 4 View Details

Active Ingredient

TADALAFIL

Application Number

21368

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

2008-01-07

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18067

Drug Name

CINOBAC

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

18067 / 1 View Details

Active Ingredient

CINOXACIN

Application Number

18067

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18067

Drug Name

CINOBAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

18067 / 2 View Details

Active Ingredient

CINOXACIN

Application Number

18067

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50345

Drug Name

CORDRAN N

Product Number

1

Dosage Form

-

Strength

0.05%;EQ 3.5MG BASE/GM

Approval Date

1982-01-01

50345 / 1 View Details

Active Ingredient

FLURANDRENOLIDE; NEOMYCIN SULFATE

Application Number

50345

Product Number

1

Dosage Form

-

Strength

0.05%;EQ 3.5MG BASE/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50346

Drug Name

CORDRAN N

Product Number

1

Dosage Form

-

Strength

0.05%;EQ 3.5MG BASE/GM

Approval Date

1982-01-01

50346 / 1 View Details

Active Ingredient

FLURANDRENOLIDE; NEOMYCIN SULFATE

Application Number

50346

Product Number

1

Dosage Form

-

Strength

0.05%;EQ 3.5MG BASE/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 84100

Drug Name

CRYSTODIGIN

Product Number

5

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

84100 / 5 View Details

Active Ingredient

DIGITOXIN

Application Number

84100

Product Number

5

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004

03 Aug

Discontinued Application: 21427

Drug Name

CYMBALTA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-08-03

21427 / 1 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21427

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-08-03

Regulatory Status

Discontinued

2004

03 Aug

Discontinued Application: 21427

Drug Name

CYMBALTA

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2004-08-03

21427 / 2 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21427

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2004-08-03

Regulatory Status

Discontinued

2004

03 Aug

Discontinued Application: 21427

Drug Name

CYMBALTA

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2004-08-03

21427 / 4 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21427

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2004-08-03

Regulatory Status

Discontinued

-

Unclassified Application: 21733

Drug Name

CYMBALTA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

21733 / 1 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21733

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21733

Drug Name

CYMBALTA

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

21733 / 2 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21733

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21733

Drug Name

CYMBALTA

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

21733 / 4 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

21733

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22148

Drug Name

CYMBALTA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

22148 / 1 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22148

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22148

Drug Name

CYMBALTA

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

22148 / 2 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22148

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22148

Drug Name

CYMBALTA

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

22148 / 3 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22148

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22516

Drug Name

CYMBALTA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

22516 / 1 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22516

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22516

Drug Name

CYMBALTA

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

22516 / 2 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22516

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 22516

Drug Name

CYMBALTA

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

22516 / 3 View Details

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

22516

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125477

Drug Name

CYRAMZA

Product Number

1

Dosage Form

-

Strength

100MG/10ML

Approval Date

-

125477 / 1 View Details

Active Ingredient

RAMUCIRUMAB

Application Number

125477

Product Number

1

Dosage Form

-

Strength

100MG/10ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125477

Drug Name

CYRAMZA

Product Number

2

Dosage Form

-

Strength

500MG/50ML

Approval Date

-

125477 / 2 View Details

Active Ingredient

RAMUCIRUMAB

Application Number

125477

Product Number

2

Dosage Form

-

Strength

500MG/50ML

Approval Date

-

Regulatory Status

Unclassified

1989

29 Dec

Discontinued Application: 19693

Drug Name

DECABID

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1989-12-29

19693 / 1 View Details

Active Ingredient

INDECAINIDE HYDROCHLORIDE

Application Number

19693

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989

29 Dec

Discontinued Application: 19693

Drug Name

DECABID

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1989-12-29

19693 / 2 View Details

Active Ingredient

INDECAINIDE HYDROCHLORIDE

Application Number

19693

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989

29 Dec

Discontinued Application: 19693

Drug Name

DECABID

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1989-12-29

19693 / 3 View Details

Active Ingredient

INDECAINIDE HYDROCHLORIDE

Application Number

19693

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1989-12-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80884

Drug Name

DELTALIN

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

80884 / 1 View Details

Active Ingredient

ERGOCALCIFEROL

Application Number

80884

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5509

Drug Name

DICUMAROL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

5509 / 1 View Details

Active Ingredient

DICUMAROL

Application Number

5509

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5509

Drug Name

DICUMAROL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

5509 / 3 View Details

Active Ingredient

DICUMAROL

Application Number

5509

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8869

Drug Name

DICURIN PROCAINE

Product Number

1

Dosage Form

-

Strength

100MG/ML;50MG/ML

Approval Date

1982-01-01

8869 / 1 View Details

Active Ingredient

PROCAINE MERETHOXYLLINE; THEOPHYLLINE

Application Number

8869

Product Number

1

Dosage Form

-

Strength

100MG/ML;50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4039

Drug Name

DIETHYLSTILBESTROL

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

4039 / 2 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4039

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4039

Drug Name

DIETHYLSTILBESTROL

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

4039 / 3 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4039

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4039

Drug Name

DIETHYLSTILBESTROL

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

4039 / 4 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4039

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4039

Drug Name

DIETHYLSTILBESTROL

Product Number

5

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

4039 / 5 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4039

Product Number

5

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4039

Drug Name

DIETHYLSTILBESTROL

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

4039 / 6 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4039

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4040

Drug Name

DIETHYLSTILBESTROL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

4040 / 1 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4040

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4040

Drug Name

DIETHYLSTILBESTROL

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

4040 / 2 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4040

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4041

Drug Name

DIETHYLSTILBESTROL

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

4041 / 2 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4041

Product Number

2

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4041

Drug Name

DIETHYLSTILBESTROL

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

4041 / 3 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4041

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4041

Drug Name

DIETHYLSTILBESTROL

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

4041 / 4 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4041

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4041

Drug Name

DIETHYLSTILBESTROL

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

4041 / 5 View Details

Active Ingredient

DIETHYLSTILBESTROL

Application Number

4041

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17820

Drug Name

DOBUTREX

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17820 / 2 View Details

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

17820

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE/ML **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: 12936

Drug Name

DROLBAN

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

12936 / 1 View Details

Active Ingredient

DROMOSTANOLONE PROPIONATE

Application Number

12936

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60093

Drug Name

DURACILLIN A.S.

Product Number

1

Dosage Form

-

Strength

300,000 UNITS/ML

Approval Date

1982-01-01

60093 / 1 View Details

Active Ingredient

PENICILLIN G PROCAINE

Application Number

60093

Product Number

1

Dosage Form

-

Strength

300,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13378

Drug Name

DYMELOR

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

13378 / 1 View Details

Active Ingredient

ACETOHEXAMIDE

Application Number

13378

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13378

Drug Name

DYMELOR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

13378 / 2 View Details

Active Ingredient

ACETOHEXAMIDE

Application Number

13378

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

19 Jun

Discontinued Application: 50678

Drug Name

DYNABAC

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-06-19

50678 / 1 View Details

Active Ingredient

DIRITHROMYCIN

Application Number

50678

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1995-06-19

Regulatory Status

Discontinued

-

Unclassified Application: 761306

Drug Name

EBGLYSS

Product Number

1

Dosage Form

-

Strength

250MG/2ML

Approval Date

-

761306 / 1 View Details

Active Ingredient

LEBRIKIZUMAB-LBKZ

Application Number

761306

Product Number

1

Dosage Form

-

Strength

250MG/2ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761063

Drug Name

EMGALITY

Product Number

1

Dosage Form

-

Strength

120MG/ML

Approval Date

-

761063 / 1 View Details

Active Ingredient

GALCANEZUMAB-GNLM

Application Number

761063

Product Number

1

Dosage Form

-

Strength

120MG/ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 50532

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

50532 / 1 View Details

Active Ingredient

ERYTHROMYCIN

Application Number

50532

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997

09 Dec

RX Application: 20815

Drug Name

EVISTA

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1997-12-09

20815 / 1 View Details

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

20815

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1997-12-09

Regulatory Status

RX

-

Unclassified Application: 22042

Drug Name

EVISTA

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

-

22042 / 1 View Details

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

22042

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 6135

Drug Name

FOLIC ACID

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

6135 / 3 View Details

Active Ingredient

FOLIC ACID

Application Number

6135

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21318

Drug Name

FORTEO

Product Number

1

Dosage Form

-

Strength

0.75MG/3ML (0.25MG/ML)

Approval Date

2002-11-26

21318 / 1 View Details

Active Ingredient

TERIPARATIDE

Application Number

21318

Product Number

1

Dosage Form

-

Strength

0.75MG/3ML (0.25MG/ML)

Approval Date

2002-11-26

Regulatory Status

Discontinued

2008

25 Jun

RX Application: 21318

Drug Name

FORTEO

Product Number

2

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2008-06-25

21318 / 2 View Details

Active Ingredient

TERIPARATIDE

Application Number

21318

Product Number

2

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2008-06-25

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2026-04-01

220934 / 1 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2026-04-01

220934 / 2 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

3

Dosage Form

-

Strength

EQ 5.5MG BASE

Approval Date

2026-04-01

220934 / 3 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

3

Dosage Form

-

Strength

EQ 5.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

4

Dosage Form

-

Strength

EQ 9MG BASE

Approval Date

2026-04-01

220934 / 4 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

4

Dosage Form

-

Strength

EQ 9MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

5

Dosage Form

-

Strength

EQ 14.5MG BASE

Approval Date

2026-04-01

220934 / 5 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

5

Dosage Form

-

Strength

EQ 14.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026

01 Apr

RX Application: 220934

Drug Name

FOUNDAYO

Product Number

6

Dosage Form

-

Strength

EQ 17.2MG BASE

Approval Date

2026-04-01

220934 / 6 View Details

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

6

Dosage Form

-

Strength

EQ 17.2MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

1996

15 May

Discontinued Application: 20509

Drug Name

GEMZAR

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-05-15

20509 / 1 View Details

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

20509

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-05-15

Regulatory Status

Discontinued

1996

15 May

Discontinued Application: 20509

Drug Name

GEMZAR

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-05-15

20509 / 2 View Details

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

20509

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-05-15

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12122

Drug Name

GLUCAGON

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12122 / 1 View Details

Active Ingredient

GLUCAGON HYDROCHLORIDE

Application Number

12122

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL **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: 12122

Drug Name

GLUCAGON

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12122 / 2 View Details

Active Ingredient

GLUCAGON HYDROCHLORIDE

Application Number

12122

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998

11 Sep

Discontinued Application: 20928

Drug Name

GLUCAGON

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-09-11

20928 / 1 View Details

Active Ingredient

GLUCAGON

Application Number

20928

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-09-11

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12772

Drug Name

HALDRONE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

12772 / 5 View Details

Active Ingredient

PARAMETHASONE ACETATE

Application Number

12772

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12772

Drug Name

HALDRONE

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12772 / 6 View Details

Active Ingredient

PARAMETHASONE ACETATE

Application Number

12772

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5521

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

5521 / 1 View Details

Active Ingredient

HEPARIN SODIUM

Application Number

5521

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5521

Drug Name

HEPARIN SODIUM

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

5521 / 2 View Details

Active Ingredient

HEPARIN SODIUM

Application Number

5521

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5521

Drug Name

HEPARIN SODIUM

Product Number

4

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

5521 / 4 View Details

Active Ingredient

HEPARIN SODIUM

Application Number

5521

Product Number

4

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80854

Drug Name

HEXA-BETALIN

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

80854 / 1 View Details

Active Ingredient

PYRIDOXINE HYDROCHLORIDE

Application Number

80854

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9344

Drug Name

HISTALOG

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

9344 / 1 View Details

Active Ingredient

BETAZOLE HYDROCHLORIDE

Application Number

9344

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 734

Drug Name

HISTAMINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

734 / 1 View Details

Active Ingredient

HISTAMINE PHOSPHATE

Application Number

734

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 734

Drug Name

HISTAMINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

1982-01-01

734 / 2 View Details

Active Ingredient

HISTAMINE PHOSPHATE

Application Number

734

Product Number

2

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 734

Drug Name

HISTAMINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1982-01-01

734 / 3 View Details

Active Ingredient

HISTAMINE PHOSPHATE

Application Number

734

Product Number

3

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 20563

Drug Name

HUMALOG

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

20563 / 1 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

20563

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20563

Drug Name

HUMALOG KWIKPEN

Product Number

3

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

20563 / 3 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

20563

Product Number

3

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20563

Drug Name

HUMALOG KWIKPEN

Product Number

4

Dosage Form

-

Strength

200UNITS/ML

Approval Date

-

20563 / 4 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

20563

Product Number

4

Dosage Form

-

Strength

200UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 205747

Drug Name

HUMALOG KWIKPEN

Product Number

1

Dosage Form

-

Strength

200 UNITS/ML

Approval Date

-

205747 / 1 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

205747

Product Number

1

Dosage Form

-

Strength

200 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21018

Drug Name

HUMALOG MIX 50/50

Product Number

1

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

21018 / 1 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21018

Product Number

1

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21018

Drug Name

HUMALOG MIX 50/50 KWIKPEN

Product Number

2

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

21018 / 2 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21018

Product Number

2

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21018

Drug Name

HUMALOG MIX 50/50 PEN

Product Number

3

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

21018 / 3 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21018

Product Number

3

Dosage Form

-

Strength

50 UNITS/ML;50 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21017

Drug Name

HUMALOG MIX 75/25

Product Number

1

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

21017 / 1 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21017

Product Number

1

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21017

Drug Name

HUMALOG MIX 75/25 KWIKPEN

Product Number

2

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

21017 / 2 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21017

Product Number

2

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21017

Drug Name

HUMALOG MIX 75/25 PEN

Product Number

3

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

21017 / 3 View Details

Active Ingredient

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Application Number

21017

Product Number

3

Dosage Form

-

Strength

75 UNITS/ML;25 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20563

Drug Name

HUMALOG PEN

Product Number

2

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

20563 / 2 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

20563

Product Number

2

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20563

Drug Name

HUMALOG TEMPO PEN

Product Number

5

Dosage Form

-

Strength

100UNITS/ML

Approval Date

-

20563 / 5 View Details

Active Ingredient

INSULIN LISPRO RECOMBINANT

Application Number

20563

Product Number

5

Dosage Form

-

Strength

100UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19640

Drug Name

HUMATROPE

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

-

19640 / 1 View Details

Active Ingredient

SOMATROPIN

Application Number

19640

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19640

Drug Name

HUMATROPE

Product Number

4

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

19640 / 4 View Details

Active Ingredient

SOMATROPIN

Application Number

19640

Product Number

4

Dosage Form

-

Strength

5MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19640

Drug Name

HUMATROPE

Product Number

5

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

19640 / 5 View Details

Active Ingredient

SOMATROPIN

Application Number

19640

Product Number

5

Dosage Form

-

Strength

6MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19640

Drug Name

HUMATROPE

Product Number

6

Dosage Form

-

Strength

12MG/VIAL

Approval Date

-

19640 / 6 View Details

Active Ingredient

SOMATROPIN

Application Number

19640

Product Number

6

Dosage Form

-

Strength

12MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19640

Drug Name

HUMATROPE

Product Number

7

Dosage Form

-

Strength

24MG/VIAL

Approval Date

-

19640 / 7 View Details

Active Ingredient

SOMATROPIN

Application Number

19640

Product Number

7

Dosage Form

-

Strength

24MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19717

Drug Name

HUMULIN 70/30

Product Number

1

Dosage Form

-

Strength

30 UNITS/ML;70 UNITS/ML

Approval Date

-

19717 / 1 View Details

Active Ingredient

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

Application Number

19717

Product Number

1

Dosage Form

-

Strength

30 UNITS/ML;70 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 19717

Drug Name

HUMULIN 70/30 PEN

Product Number

2

Dosage Form

-

Strength

30 UNITS/ML;70 UNITS/ML

Approval Date

-

19717 / 2 View Details

Active Ingredient

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

Application Number

19717

Product Number

2

Dosage Form

-

Strength

30 UNITS/ML;70 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 18781

Drug Name

HUMULIN N

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

18781 / 1 View Details

Active Ingredient

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

Application Number

18781

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 18780

Drug Name

HUMULIN R

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

18780 / 1 View Details

Active Ingredient

INSULIN RECOMBINANT HUMAN

Application Number

18780

Product Number

1

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 18780

Drug Name

HUMULIN R

Product Number

4

Dosage Form

-

Strength

10000 UNITS/20ML (500 UNITS/ML)

Approval Date

-

18780 / 4 View Details

Active Ingredient

INSULIN HUMAN

Application Number

18780

Product Number

4

Dosage Form

-

Strength

10000 UNITS/20ML (500 UNITS/ML)

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 18780

Drug Name

HUMULIN R KWIKPEN

Product Number

2

Dosage Form

-

Strength

1500 UNITS/3ML (500 UNITS/ML)

Approval Date

-

18780 / 2 View Details

Active Ingredient

INSULIN HUMAN

Application Number

18780

Product Number

2

Dosage Form

-

Strength

1500 UNITS/3ML (500 UNITS/ML)

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 18780

Drug Name

HUMULIN R PEN

Product Number

5

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

18780 / 5 View Details

Active Ingredient

INSULIN RECOMBINANT HUMAN

Application Number

18780

Product Number

5

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 50010

Drug Name

ILOSONE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

50010 / 1 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

50010

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50010

Drug Name

ILOSONE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

50010 / 2 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

50010

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61894

Drug Name

ILOSONE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

61894 / 1 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61894

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61894

Drug Name

ILOSONE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

61894 / 2 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61894

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61894

Drug Name

ILOSONE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1982-01-01

61894 / 3 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61894

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61896

Drug Name

ILOSONE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61896 / 1 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61896

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61897

Drug Name

ILOSONE

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

61897 / 1 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61897

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 61897

Drug Name

ILOSONE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61897 / 2 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE

Application Number

61897

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989

29 Sep

Discontinued Application: 50599

Drug Name

ILOSONE SULFA

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML;EQ 600MG BASE/5ML

Approval Date

1989-09-29

50599 / 1 View Details

Active Ingredient

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL

Application Number

50599

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML;EQ 600MG BASE/5ML

Approval Date

1989-09-29

Regulatory Status

Discontinued

2025

25 Sep

RX Application: 218881

Drug Name

INLURIYO

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-09-25

218881 / 1 View Details

Active Ingredient

IMLUNESTRANT TOSYLATE

Application Number

218881

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-09-25

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 8499

Drug Name

ISONIAZID

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

8499 / 2 View Details

Active Ingredient

ISONIAZID

Application Number

8499

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8499

Drug Name

ISONIAZID

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

8499 / 3 View Details

Active Ingredient

ISONIAZID

Application Number

8499

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50219

Drug Name

KAFOCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

50219 / 1 View Details

Active Ingredient

CEPHALOGLYCIN

Application Number

50219

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5725

Drug Name

KAPPADIONE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

5725 / 1 View Details

Active Ingredient

MENADIOL SODIUM DIPHOSPHATE

Application Number

5725

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50440

Drug Name

KEFLET

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50440 / 1 View Details

Active Ingredient

CEPHALEXIN

Application Number

50440

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE **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: 50440

Drug Name

KEFLET

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1982-01-01

50440 / 2 View Details

Active Ingredient

CEPHALEXIN

Application Number

50440

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

26 Feb

Discontinued Application: 50440

Drug Name

KEFLET

Product Number

3

Dosage Form

-

Strength

EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-26

50440 / 3 View Details

Active Ingredient

CEPHALEXIN

Application Number

50440

Product Number

3

Dosage Form

-

Strength

EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-26

Regulatory Status

Discontinued

1986

01 Dec

Discontinued Application: 62745

Drug Name

KEFLET

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-12-01

62745 / 1 View Details

Active Ingredient

CEPHALEXIN

Application Number

62745

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1986-12-01

Regulatory Status

Discontinued

1986

01 Dec

Discontinued Application: 62745

Drug Name

KEFLET

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1986-12-01

62745 / 2 View Details

Active Ingredient

CEPHALEXIN

Application Number

62745

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1986-12-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50482

Drug Name

KEFLIN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50482 / 1 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

50482

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50482

Drug Name

KEFLIN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

50482 / 2 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

50482

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50482

Drug Name

KEFLIN

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1982-01-01

50482 / 3 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

50482

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50482

Drug Name

KEFLIN

Product Number

7

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

50482 / 7 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

50482

Product Number

7

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62549

Drug Name

KEFLIN IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

62549 / 1 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62549

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62549

Drug Name

KEFLIN IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1985-09-10

62549 / 2 View Details

Active Ingredient

CEPHALOTHIN SODIUM

Application Number

62549

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

1987

29 Oct

Discontinued Application: 50614

Drug Name

KEFTAB

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-10-29

50614 / 1 View Details

Active Ingredient

CEPHALEXIN HYDROCHLORIDE

Application Number

50614

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-10-29

Regulatory Status

Discontinued

1987

29 Oct

Discontinued Application: 50614

Drug Name

KEFTAB

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-10-29

50614 / 2 View Details

Active Ingredient

CEPHALEXIN HYDROCHLORIDE

Application Number

50614

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-10-29

Regulatory Status

Discontinued

1988

16 May

Discontinued Application: 50614

Drug Name

KEFTAB

Product Number

3

Dosage Form

-

Strength

EQ 333MG BASE

Approval Date

1988-05-16

50614 / 3 View Details

Active Ingredient

CEPHALEXIN HYDROCHLORIDE

Application Number

50614

Product Number

3

Dosage Form

-

Strength

EQ 333MG BASE

Approval Date

1988-05-16

Regulatory Status

Discontinued

1986

10 Jan

Discontinued Application: 62592

Drug Name

KEFUROX

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1986-01-10

62592 / 1 View Details

Active Ingredient

CEFUROXIME SODIUM

Application Number

62592

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1986-01-10

Regulatory Status

Discontinued

1986

10 Jan

Discontinued Application: 62592

Drug Name

KEFUROX

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1986-01-10

62592 / 2 View Details

Active Ingredient

CEFUROXIME SODIUM

Application Number

62592

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1986-01-10

Regulatory Status

Discontinued

1986

10 Jan

Discontinued Application: 62590

Drug Name

KEFUROX IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1986-01-10

62590 / 1 View Details

Active Ingredient

CEFUROXIME SODIUM

Application Number

62590

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

1986-01-10

Regulatory Status

Discontinued

1986

10 Jan

Discontinued Application: 62590

Drug Name

KEFUROX IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1986-01-10

62590 / 2 View Details

Active Ingredient

CEFUROXIME SODIUM

Application Number

62590

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

1986-01-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62557

Drug Name

KEFZOL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-09-10

62557 / 1 View Details

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62557

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62557

Drug Name

KEFZOL

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

62557 / 2 View Details

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62557

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

-

Unclassified Application: 761248

Drug Name

KISUNLA

Product Number

1

Dosage Form

-

Strength

350MG/20ML(17.5MG/ML)

Approval Date

-

761248 / 1 View Details

Active Ingredient

DONANEMAB-AZBT

Application Number

761248

Product Number

1

Dosage Form

-

Strength

350MG/20ML(17.5MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761038

Drug Name

LARTRUVO

Product Number

1

Dosage Form

-

Strength

500MG/50ML

Approval Date

-

761038 / 1 View Details

Active Ingredient

OLARATUMAB

Application Number

761038

Product Number

1

Dosage Form

-

Strength

500MG/50ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761109

Drug Name

LYUMJEV

Product Number

1

Dosage Form

-

Strength

100UNITS/ML(U-100)

Approval Date

-

761109 / 1 View Details

Active Ingredient

INSULIN LISPRO-AABC

Application Number

761109

Product Number

1

Dosage Form

-

Strength

100UNITS/ML(U-100)

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761109

Drug Name

LYUMJEV

Product Number

2

Dosage Form

-

Strength

200UNITS/ML(U-200)

Approval Date

-

761109 / 2 View Details

Active Ingredient

INSULIN LISPRO-AABC

Application Number

761109

Product Number

2

Dosage Form

-

Strength

200UNITS/ML(U-200)

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 50504

Drug Name

MANDOL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

50504 / 1 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

50504

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50504

Drug Name

MANDOL

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50504 / 2 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

50504

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50504

Drug Name

MANDOL

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

50504 / 3 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

50504

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50504

Drug Name

MANDOL

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

50504 / 4 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

50504

Product Number

4

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62560

Drug Name

MANDOL

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

62560 / 1 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

62560

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

1985

10 Sep

Discontinued Application: 62560

Drug Name

MANDOL

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1985-09-10

62560 / 2 View Details

Active Ingredient

CEFAMANDOLE NAFATE

Application Number

62560

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1985-09-10

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 2139

Drug Name

MENADIONE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

2139 / 3 View Details

Active Ingredient

MENADIONE

Application Number

2139

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80256

Drug Name

METHYLTESTOSTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

80256 / 1 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

80256

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80256

Drug Name

METHYLTESTOSTERONE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80256 / 2 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

80256

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6632

Drug Name

METUBINE IODIDE

Product Number

3

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-01-01

6632 / 3 View Details

Active Ingredient

METOCURINE IODIDE

Application Number

6632

Product Number

3

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 7 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-07-28

215866 / 8 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 9 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-07-28

215866 / 10 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 11 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023

28 Jul

RX Application: 215866

Drug Name

MOUNJARO

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-07-28

215866 / 12 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

215866 / 13 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

215866 / 14 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

215866 / 15 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

215866 / 16 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

215866 / 17 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 215866

Drug Name

MOUNJARO

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

215866 / 18 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 1 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2022-05-13

215866 / 2 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 3 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2022-05-13

215866 / 4 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 5 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022

13 May

RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2022-05-13

215866 / 6 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

215866 / 19 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

215866 / 20 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

215866 / 21 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

215866 / 22 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

215866 / 23 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

215866 / 24 View Details

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 50550

Drug Name

MOXAM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

50550 / 1 View Details

Active Ingredient

MOXALACTAM DISODIUM

Application Number

50550

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50550

Drug Name

MOXAM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

50550 / 2 View Details

Active Ingredient

MOXALACTAM DISODIUM

Application Number

50550

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50550

Drug Name

MOXAM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50550 / 3 View Details

Active Ingredient

MOXALACTAM DISODIUM

Application Number

50550

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50550

Drug Name

MOXAM

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

50550 / 4 View Details

Active Ingredient

MOXALACTAM DISODIUM

Application Number

50550

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50550

Drug Name

MOXAM

Product Number

8

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

50550 / 8 View Details

Active Ingredient

MOXALACTAM DISODIUM

Application Number

50550

Product Number

8

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 50477

Drug Name

NEBCIN

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50477 / 5 View Details

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

50477

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE/ML **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: 50519

Drug Name

NEBCIN

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50519 / 1 View Details

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

50519

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL **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: 62008

Drug Name

NEBCIN

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

62008 / 1 View Details

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

62008

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 62008

Drug Name

NEBCIN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

62008 / 4 View Details

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

62008

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

29 Apr

Discontinued Application: 62707

Drug Name

NEBCIN

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1987-04-29

62707 / 1 View Details

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

62707

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1987-04-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60385

Drug Name

NEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60385 / 1 View Details

Active Ingredient

NEOMYCIN SULFATE

Application Number

60385

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6317

Drug Name

NEOTRIZINE

Product Number

11

Dosage Form

-

Strength

167MG;167MG;167MG

Approval Date

1982-01-01

6317 / 11 View Details

Active Ingredient

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

Application Number

6317

Product Number

11

Dosage Form

-

Strength

167MG;167MG;167MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6317

Drug Name

NEOTRIZINE

Product Number

12

Dosage Form

-

Strength

167MG/5ML;167MG/5ML;167MG/5ML

Approval Date

1982-01-01

6317 / 12 View Details

Active Ingredient

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

Application Number

6317

Product Number

12

Dosage Form

-

Strength

167MG/5ML;167MG/5ML;167MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12928

Drug Name

NOVRAD

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/5ML

Approval Date

1982-01-01

12928 / 2 View Details

Active Ingredient

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

Application Number

12928

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12928

Drug Name

NOVRAD

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-01-01

12928 / 4 View Details

Active Ingredient

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

Application Number

12928

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12928

Drug Name

NOVRAD

Product Number

6

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-01-01

12928 / 6 View Details

Active Ingredient

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

Application Number

12928

Product Number

6

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2018

31 May

RX Application: 207924

Drug Name

OLUMIANT

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2018-05-31

207924 / 1 View Details

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2018-05-31

Regulatory Status

RX

2019

08 Oct

RX Application: 207924

Drug Name

OLUMIANT

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2019-10-08

207924 / 2 View Details

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2019-10-08

Regulatory Status

RX

2022

10 May

RX Application: 207924

Drug Name

OLUMIANT

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-10

207924 / 3 View Details

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-10

Regulatory Status

RX

-

Unclassified Application: 761279

Drug Name

OMVOH

Product Number

1

Dosage Form

-

Strength

300MG/15ML

Approval Date

-

761279 / 1 View Details

Active Ingredient

MIRIKIZUMAB-MRKZ

Application Number

761279

Product Number

1

Dosage Form

-

Strength

300MG/15ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761279

Drug Name

OMVOH

Product Number

2

Dosage Form

-

Strength

100MG/ML

Approval Date

-

761279 / 2 View Details

Active Ingredient

MIRIKIZUMAB-MRKZ

Application Number

761279

Product Number

2

Dosage Form

-

Strength

100MG/ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 14103

Drug Name

ONCOVIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

14103 / 1 View Details

Active Ingredient

VINCRISTINE SULFATE

Application Number

14103

Product Number

1

Dosage Form

-

Strength

1MG/VIAL **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: 14103

Drug Name

ONCOVIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

14103 / 2 View Details

Active Ingredient

VINCRISTINE SULFATE

Application Number

14103

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984

07 Mar

Discontinued Application: 14103

Drug Name

ONCOVIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-03-07

14103 / 3 View Details

Active Ingredient

VINCRISTINE SULFATE

Application Number

14103

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-03-07

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8951

Drug Name

PAGITANE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

8951 / 1 View Details

Active Ingredient

CYCRIMINE HYDROCHLORIDE

Application Number

8951

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8951

Drug Name

PAGITANE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

8951 / 2 View Details

Active Ingredient

CYCRIMINE HYDROCHLORIDE

Application Number

8951

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60384

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

1982-01-01

60384 / 1 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60384

Product Number

1

Dosage Form

-

Strength

5,000,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60384

Drug Name

PENICILLIN G POTASSIUM

Product Number

2

Dosage Form

-

Strength

1,000,000 UNITS/VIAL

Approval Date

1982-01-01

60384 / 2 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60384

Product Number

2

Dosage Form

-

Strength

1,000,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60384

Drug Name

PENICILLIN G POTASSIUM

Product Number

3

Dosage Form

-

Strength

500,000 UNITS/VIAL

Approval Date

1982-01-01

60384 / 3 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60384

Product Number

3

Dosage Form

-

Strength

500,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60384

Drug Name

PENICILLIN G POTASSIUM

Product Number

4

Dosage Form

-

Strength

200,000 UNITS/VIAL

Approval Date

1982-01-01

60384 / 4 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60384

Product Number

4

Dosage Form

-

Strength

200,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60384

Drug Name

PENICILLIN G POTASSIUM

Product Number

5

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

1982-01-01

60384 / 5 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60384

Product Number

5

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60403

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

60403 / 1 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60403

Product Number

1

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60601

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

1982-01-01

60601 / 1 View Details

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60601

Product Number

1

Dosage Form

-

Strength

20,000,000 UNITS/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 125547

Drug Name

PORTRAZZA

Product Number

1

Dosage Form

-

Strength

800MG/50ML

Approval Date

-

125547 / 1 View Details

Active Ingredient

NECITUMUMAB

Application Number

125547

Product Number

1

Dosage Form

-

Strength

800MG/50ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 7865

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

7865 / 2 View Details

Active Ingredient

POTASSIUM CHLORIDE

Application Number

7865

Product Number

2

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9238

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

9238 / 1 View Details

Active Ingredient

PROGESTERONE

Application Number

9238

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9238

Drug Name

PROGESTERONE

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

9238 / 2 View Details

Active Ingredient

PROGESTERONE

Application Number

9238

Product Number

2

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6213

Drug Name

PROPYLTHIOURACIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

6213 / 1 View Details

Active Ingredient

PROPYLTHIOURACIL

Application Number

6213

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6460

Drug Name

PROTAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6460 / 2 View Details

Active Ingredient

PROTAMINE SULFATE

Application Number

6460

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML) **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: 6460

Drug Name

PROTAMINE SULFATE

Product Number

3

Dosage Form

-

Strength

250MG/25ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6460 / 3 View Details

Active Ingredient

PROTAMINE SULFATE

Application Number

6460

Product Number

3

Dosage Form

-

Strength

250MG/25ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

29 Dec

Discontinued Application: 18936

Drug Name

PROZAC

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1987-12-29

18936 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1987-12-29

Regulatory Status

Discontinued

1999

15 Jun

Discontinued Application: 18936

Drug Name

PROZAC

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1999-06-15

18936 / 3 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1999-06-15

Regulatory Status

Discontinued

1999

15 Jun

Discontinued Application: 18936

Drug Name

PROZAC

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

1999-06-15

18936 / 4 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

1999-06-15

Regulatory Status

Discontinued

1992

23 Dec

Discontinued Application: 18936

Drug Name

PROZAC

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-23

18936 / 6 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

6

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1992-12-23

Regulatory Status

Discontinued

1991

24 Apr

Discontinued Application: 20101

Drug Name

PROZAC

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-04-24

20101 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

20101

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-04-24

Regulatory Status

Discontinued

1999

09 Mar

Discontinued Application: 20974

Drug Name

PROZAC

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

1999-03-09

20974 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

20974

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

1999-03-09

Regulatory Status

Discontinued

1999

09 Mar

Discontinued Application: 20974

Drug Name

PROZAC

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

1999-03-09

20974 / 2 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

20974

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

1999-03-09

Regulatory Status

Discontinued

2001

26 Feb

Discontinued Application: 21235

Drug Name

PROZAC WEEKLY

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-26

21235 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

21235

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-26

Regulatory Status

Discontinued

1989

10 Feb

Discontinued Application: 7529

Drug Name

QUINIDINE GLUCONATE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1989-02-10

7529 / 2 View Details

Active Ingredient

QUINIDINE GLUCONATE

Application Number

7529

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1989-02-10

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 85038

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

85038 / 1 View Details

Active Ingredient

QUINIDINE SULFATE

Application Number

85038

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 85103

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

85103 / 1 View Details

Active Ingredient

QUINIDINE SULFATE

Application Number

85103

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020

08 May

RX Application: 213246

Drug Name

RETEVMO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2020-05-08

213246 / 1 View Details

Active Ingredient

SELPERCATINIB

Application Number

213246

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2020-05-08

Regulatory Status

RX

2020

08 May

RX Application: 213246

Drug Name

RETEVMO

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2020-05-08

213246 / 2 View Details

Active Ingredient

SELPERCATINIB

Application Number

213246

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2020-05-08

Regulatory Status

RX

2024

10 Apr

RX Application: 218160

Drug Name

RETEVMO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-04-10

218160 / 1 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-04-10

Regulatory Status

RX

2024

10 Apr

RX Application: 218160

Drug Name

RETEVMO

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-04-10

218160 / 2 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-04-10

Regulatory Status

RX

2024

10 Apr

RX Application: 218160

Drug Name

RETEVMO

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-04-10

218160 / 3 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-04-10

Regulatory Status

RX

2024

10 Apr

RX Application: 218160

Drug Name

RETEVMO

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-04-10

218160 / 4 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-04-10

Regulatory Status

RX

-

Unclassified Application: 218160

Drug Name

RETEVMO

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

-

218160 / 5 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 218160

Drug Name

RETEVMO

Product Number

6

Dosage Form

-

Strength

80MG

Approval Date

-

218160 / 6 View Details

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

6

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

2020

31 Jan

Discontinued Application: 211280

Drug Name

REYVOW

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-01-31

211280 / 1 View Details

Active Ingredient

LASMIDITAN SUCCINATE

Application Number

211280

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2020-01-31

Regulatory Status

Discontinued

2020

31 Jan

Discontinued Application: 211280

Drug Name

REYVOW

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-01-31

211280 / 2 View Details

Active Ingredient

LASMIDITAN SUCCINATE

Application Number

211280

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-01-31

Regulatory Status

Discontinued

2020

18 Dec

Discontinued Application: 211280

Drug Name

REYVOW

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-12-18

211280 / 3 View Details

Active Ingredient

LASMIDITAN SUCCINATE

Application Number

211280

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-12-18

Regulatory Status

Discontinued

-

Unclassified Application: 761215

Drug Name

REZVOGLAR

Product Number

1

Dosage Form

-

Strength

3ML(100UNITS/ML)

Approval Date

-

761215 / 1 View Details

Active Ingredient

INSULIN GLARGINE-AGLR

Application Number

761215

Product Number

1

Dosage Form

-

Strength

3ML(100UNITS/ML)

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 9376

Drug Name

SANDRIL

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

9376 / 1 View Details

Active Ingredient

RESERPINE

Application Number

9376

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9376

Drug Name

SANDRIL

Product Number

4

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

9376 / 4 View Details

Active Ingredient

RESERPINE

Application Number

9376

Product Number

4

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10012

Drug Name

SANDRIL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

10012 / 1 View Details

Active Ingredient

RESERPINE

Application Number

10012

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000

06 Jul

Discontinued Application: 18936

Drug Name

SARAFEM

Product Number

7

Dosage Form

-

Strength

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

Approval Date

2000-07-06

18936 / 7 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

7

Dosage Form

-

Strength

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

Approval Date

2000-07-06

Regulatory Status

Discontinued

2000

06 Jul

Discontinued Application: 18936

Drug Name

SARAFEM

Product Number

8

Dosage Form

-

Strength

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

Approval Date

2000-07-06

18936 / 8 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

18936

Product Number

8

Dosage Form

-

Strength

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

Approval Date

2000-07-06

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 7392

Drug Name

SECONAL SODIUM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

7392 / 2 View Details

Active Ingredient

SECOBARBITAL SODIUM

Application Number

7392

Product Number

2

Dosage Form

-

Strength

50MG/ML **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: 86530

Drug Name

SECONAL SODIUM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

86530 / 1 View Details

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86530

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 86530

Drug Name

SECONAL SODIUM

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1982-01-01

86530 / 2 View Details

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86530

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 86530

Drug Name

SECONAL SODIUM

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1982-01-01

86530 / 3 View Details

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86530

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 86530

Drug Name

SECONAL SODIUM

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

86530 / 4 View Details

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86530

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-11-26

21411 / 1 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-11-26

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-11-26

21411 / 2 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-11-26

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-11-26

21411 / 3 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-11-26

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2002-11-26

21411 / 4 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2002-11-26

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2002-11-26

21411 / 5 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2002-11-26

Regulatory Status

Discontinued

2002

26 Nov

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-11-26

21411 / 6 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-11-26

Regulatory Status

Discontinued

2005

14 Feb

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

7

Dosage Form

-

Strength

EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-02-14

21411 / 7 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

7

Dosage Form

-

Strength

EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-02-14

Regulatory Status

Discontinued

2005

14 Feb

Discontinued Application: 21411

Drug Name

STRATTERA

Product Number

8

Dosage Form

-

Strength

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

Approval Date

2005-02-14

21411 / 8 View Details

Active Ingredient

ATOMOXETINE HYDROCHLORIDE

Application Number

21411

Product Number

8

Dosage Form

-

Strength

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

Approval Date

2005-02-14

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60107

Drug Name

STREPTOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

60107 / 1 View Details

Active Ingredient

STREPTOMYCIN SULFATE

Application Number

60107

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60107

Drug Name

STREPTOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1982-01-01

60107 / 2 View Details

Active Ingredient

STREPTOMYCIN SULFATE

Application Number

60107

Product Number

2

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60404

Drug Name

STREPTOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/2ML

Approval Date

1982-01-01

60404 / 1 View Details

Active Ingredient

STREPTOMYCIN SULFATE

Application Number

60404

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/2ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 4122

Drug Name

SULFADIAZINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

4122 / 2 View Details

Active Ingredient

SULFADIAZINE

Application Number

4122

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 159

Drug Name

SULFAPYRIDINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

159 / 1 View Details

Active Ingredient

SULFAPYRIDINE

Application Number

159

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6317

Drug Name

SULFONAMIDES DUPLEX

Product Number

7

Dosage Form

-

Strength

250MG/5ML;250MG/5ML

Approval Date

1982-01-01

6317 / 7 View Details

Active Ingredient

SULFADIAZINE; SULFAMERAZINE

Application Number

6317

Product Number

7

Dosage Form

-

Strength

250MG/5ML;250MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007

09 Apr

Discontinued Application: 21520

Drug Name

SYMBYAX

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-04-09

21520 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

21520

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-04-09

Regulatory Status

Discontinued

2003

24 Dec

Discontinued Application: 21520

Drug Name

SYMBYAX

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

21520 / 2 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

21520

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

Regulatory Status

Discontinued

2003

24 Dec

Discontinued Application: 21520

Drug Name

SYMBYAX

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

21520 / 3 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

21520

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

Regulatory Status

Discontinued

2003

24 Dec

Discontinued Application: 21520

Drug Name

SYMBYAX

Product Number

4

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

21520 / 4 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

21520

Product Number

4

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

Regulatory Status

Discontinued

2003

24 Dec

Discontinued Application: 21520

Drug Name

SYMBYAX

Product Number

5

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

21520 / 5 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

21520

Product Number

5

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-12-24

Regulatory Status

Discontinued

-

Unclassified Application: 125521

Drug Name

TALTZ

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

-

125521 / 1 View Details

Active Ingredient

IXEKIZUMAB

Application Number

125521

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

-

Regulatory Status

Unclassified

1985

20 Nov

Discontinued Application: 62655

Drug Name

TAZIDIME

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1985-11-20

62655 / 1 View Details

Active Ingredient

CEFTAZIDIME

Application Number

62655

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1985-11-20

Regulatory Status

Discontinued

1985

20 Nov

Discontinued Application: 62655

Drug Name

TAZIDIME

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1985-11-20

62655 / 2 View Details

Active Ingredient

CEFTAZIDIME

Application Number

62655

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1985-11-20

Regulatory Status

Discontinued

1986

10 Jul

Discontinued Application: 62739

Drug Name

TAZIDIME IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-07-10

62739 / 1 View Details

Active Ingredient

CEFTAZIDIME

Application Number

62739

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-07-10

Regulatory Status

Discontinued

1986

10 Jul

Discontinued Application: 62739

Drug Name

TAZIDIME IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-07-10

62739 / 2 View Details

Active Ingredient

CEFTAZIDIME

Application Number

62739

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-07-10

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80254

Drug Name

TESTOSTERONE PROPIONATE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

80254 / 2 View Details

Active Ingredient

TESTOSTERONE PROPIONATE

Application Number

80254

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 125469

Drug Name

TRULICITY

Product Number

1

Dosage Form

-

Strength

0.75MG/0.5ML

Approval Date

-

125469 / 1 View Details

Active Ingredient

DULAGLUTIDE

Application Number

125469

Product Number

1

Dosage Form

-

Strength

0.75MG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125469

Drug Name

TRULICITY

Product Number

2

Dosage Form

-

Strength

1.5MG/0.5ML

Approval Date

-

125469 / 2 View Details

Active Ingredient

DULAGLUTIDE

Application Number

125469

Product Number

2

Dosage Form

-

Strength

1.5MG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125469

Drug Name

TRULICITY

Product Number

3

Dosage Form

-

Strength

3MG/0.5ML

Approval Date

-

125469 / 3 View Details

Active Ingredient

DULAGLUTIDE

Application Number

125469

Product Number

3

Dosage Form

-

Strength

3MG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125469

Drug Name

TRULICITY

Product Number

4

Dosage Form

-

Strength

4.5MG/0.5ML

Approval Date

-

125469 / 4 View Details

Active Ingredient

DULAGLUTIDE

Application Number

125469

Product Number

4

Dosage Form

-

Strength

4.5MG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 6325

Drug Name

TUBOCURARINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

1982-01-01

6325 / 1 View Details

Active Ingredient

TUBOCURARINE CHLORIDE

Application Number

6325

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60002

Drug Name

V-CILLIN

Product Number

1

Dosage Form

-

Strength

125MG/0.6ML

Approval Date

1982-01-01

60002 / 1 View Details

Active Ingredient

PENICILLIN V

Application Number

60002

Product Number

1

Dosage Form

-

Strength

125MG/0.6ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60003

Drug Name

V-CILLIN K

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

60003 / 1 View Details

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60003

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE **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: 60003

Drug Name

V-CILLIN K

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

60003 / 2 View Details

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60003

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE **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: 60003

Drug Name

V-CILLIN K

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

60003 / 3 View Details

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60003

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE **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: 60004

Drug Name

V-CILLIN K

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

60004 / 1 View Details

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60004

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 60004

Drug Name

V-CILLIN K

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

60004 / 2 View Details

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

60004

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12665

Drug Name

VELBAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12665 / 1 View Details

Active Ingredient

VINBLASTINE SULFATE

Application Number

12665

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017

28 Sep

RX Application: 208716

Drug Name

VERZENIO

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-09-28

208716 / 1 View Details

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-09-28

Regulatory Status

RX

2017

28 Sep

RX Application: 208716

Drug Name

VERZENIO

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

208716 / 2 View Details

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

Regulatory Status

RX

2017

28 Sep

RX Application: 208716

Drug Name

VERZENIO

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2017-09-28

208716 / 3 View Details

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2017-09-28

Regulatory Status

RX

2017

28 Sep

RX Application: 208716

Drug Name

VERZENIO

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

208716 / 4 View Details

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

Regulatory Status

RX

-

Unclassified Application: 208855

Drug Name

VERZENIO

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

208855 / 1 View Details

Active Ingredient

ABEMACICLIB

Application Number

208855

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 208855

Drug Name

VERZENIO

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

208855 / 2 View Details

Active Ingredient

ABEMACICLIB

Application Number

208855

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 208855

Drug Name

VERZENIO

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

208855 / 3 View Details

Active Ingredient

ABEMACICLIB

Application Number

208855

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 208855

Drug Name

VERZENIO

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

208855 / 4 View Details

Active Ingredient

ABEMACICLIB

Application Number

208855

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 7 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2024-03-28

217806 / 8 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 9 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2024-03-28

217806 / 10 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 11 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024

28 Mar

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2024-03-28

217806 / 12 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

217806 / 13 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

217806 / 14 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

217806 / 15 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

217806 / 16 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

217806 / 17 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026

07 Jan

RX Application: 217806

Drug Name

ZEPBOUND

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

217806 / 18 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 1 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-11-08

217806 / 2 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 3 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-11-08

217806 / 4 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 5 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023

08 Nov

RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-11-08

217806 / 6 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

217806 / 19 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

217806 / 20 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

217806 / 21 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

217806 / 22 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

217806 / 23 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026

20 Jan

RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

217806 / 24 View Details

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

Eli Lilly
FDA Approved Drugs

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Company Overview

Company Snapshot

FDA Approved Drug Records ( 339 records )

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FDA Approved Drugs