Novartis Pharmaceuticals Corporation

1982

01 Jan

Discontinued Application: 9436

Drug Name

ACYLANID

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

9436 / 1 View Details

Active Ingredient

ACETYLDIGITOXIN

Application Number

9436

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 761128

Drug Name

ADAKVEO

Product Number

1

Dosage Form

-

Strength

100MG/10ML

Approval Date

-

761128 / 1 View Details

Active Ingredient

CRIZANLIZUMAB-TMCA

Application Number

761128

Product Number

1

Dosage Form

-

Strength

100MG/10ML

Approval Date

-

Regulatory Status

Unclassified

2009

30 Mar

RX Application: 22334

Drug Name

AFINITOR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-03-30

22334 / 1 View Details

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-03-30

Regulatory Status

RX

2009

30 Mar

RX Application: 22334

Drug Name

AFINITOR

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-03-30

22334 / 2 View Details

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-03-30

Regulatory Status

RX

2010

09 Jul

RX Application: 22334

Drug Name

AFINITOR

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2010-07-09

22334 / 3 View Details

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2010-07-09

Regulatory Status

RX

2012

30 Mar

RX Application: 22334

Drug Name

AFINITOR

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2012-03-30

22334 / 4 View Details

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2012-03-30

Regulatory Status

RX

2012

29 Aug

RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2012-08-29

203985 / 1 View Details

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2012-08-29

Regulatory Status

RX

2012

29 Aug

RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2012-08-29

203985 / 2 View Details

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2012-08-29

Regulatory Status

RX

2012

29 Aug

RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2012-08-29

203985 / 3 View Details

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2012-08-29

Regulatory Status

RX

1993

23 Sep

Discontinued Application: 20191

Drug Name

ALOMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1993-09-23

20191 / 1 View Details

Active Ingredient

LODOXAMIDE TROMETHAMINE

Application Number

20191

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1993-09-23

Regulatory Status

Discontinued

2010

21 Dec

Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 1 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010

21 Dec

Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 2 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010

21 Dec

Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;25MG

Approval Date

2010-12-21

200045 / 3 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE;25MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010

21 Dec

Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;12.5MG

Approval Date

2010-12-21

200045 / 4 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;12.5MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

2010

21 Dec

Discontinued Application: 200045

Drug Name

AMTURNIDE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;25MG

Approval Date

2010-12-21

200045 / 5 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Application Number

200045

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE;25MG

Approval Date

2010-12-21

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8492

Drug Name

ANTRENYL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

8492 / 2 View Details

Active Ingredient

OXYPHENONIUM BROMIDE

Application Number

8492

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11556

Drug Name

ANTURANE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11556 / 3 View Details

Active Ingredient

SULFINPYRAZONE

Application Number

11556

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11556

Drug Name

ANTURANE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11556 / 4 View Details

Active Ingredient

SULFINPYRAZONE

Application Number

11556

Product Number

4

Dosage Form

-

Strength

200MG **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: 84735

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

84735 / 1 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84735

Product Number

1

Dosage Form

-

Strength

25MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 84810

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1982-01-01

84810 / 1 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84810

Product Number

1

Dosage Form

-

Strength

50MG;50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 84811

Drug Name

APRESAZIDE

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1982-01-01

84811 / 1 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

84811

Product Number

1

Dosage Form

-

Strength

100MG;50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8303

Drug Name

APRESOLINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8303 / 1 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8303

Drug Name

APRESOLINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8303 / 2 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8303

Drug Name

APRESOLINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8303 / 3 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

3

Dosage Form

-

Strength

20MG/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: 8303

Drug Name

APRESOLINE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8303 / 4 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8303

Drug Name

APRESOLINE

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8303 / 5 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

8303

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12026

Drug Name

APRESOLINE-ESIDRIX

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

1982-01-01

12026 / 2 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

12026

Product Number

2

Dosage Form

-

Strength

25MG;15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011

01 Jul

Discontinued Application: 22383

Drug Name

ARCAPTA NEOHALER

Product Number

1

Dosage Form

-

Strength

EQ 75MCG BASE

Approval Date

2011-07-01

22383 / 1 View Details

Active Ingredient

INDACATEROL MALEATE

Application Number

22383

Product Number

1

Dosage Form

-

Strength

EQ 75MCG BASE

Approval Date

2011-07-01

Regulatory Status

Discontinued

1991

31 Oct

Discontinued Application: 20036

Drug Name

AREDIA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-10-31

20036 / 1 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-10-31

Regulatory Status

Discontinued

1993

06 May

Discontinued Application: 20036

Drug Name

AREDIA

Product Number

3

Dosage Form

-

Strength

60MG/VIAL

Approval Date

1993-05-06

20036 / 3 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

3

Dosage Form

-

Strength

60MG/VIAL

Approval Date

1993-05-06

Regulatory Status

Discontinued

1993

06 May

Discontinued Application: 20036

Drug Name

AREDIA

Product Number

4

Dosage Form

-

Strength

90MG/VIAL

Approval Date

1993-05-06

20036 / 4 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20036

Product Number

4

Dosage Form

-

Strength

90MG/VIAL

Approval Date

1993-05-06

Regulatory Status

Discontinued

-

Unclassified Application: 20927

Drug Name

AREDIA

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

-

20927 / 1 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20927

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20927

Drug Name

AREDIA

Product Number

2

Dosage Form

-

Strength

60MG/VIAL

Approval Date

-

20927 / 2 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20927

Product Number

2

Dosage Form

-

Strength

60MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 20927

Drug Name

AREDIA

Product Number

3

Dosage Form

-

Strength

90MG/VIAL

Approval Date

-

20927 / 3 View Details

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

20927

Product Number

3

Dosage Form

-

Strength

90MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 125326

Drug Name

ARZERRA

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

-

125326 / 1 View Details

Active Ingredient

OFATUMUMAB

Application Number

125326

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 85148

Drug Name

ASBRON

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1982-01-01

85148 / 1 View Details

Active Ingredient

THEOPHYLLINE SODIUM GLYCINATE

Application Number

85148

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 761125

Drug Name

BEOVU

Product Number

1

Dosage Form

-

Strength

6MG/0.05ML

Approval Date

-

761125 / 1 View Details

Active Ingredient

brolucizumab-dbll

Application Number

761125

Product Number

1

Dosage Form

-

Strength

6MG/0.05ML

Approval Date

-

Regulatory Status

Unclassified

1989

29 Dec

RX Application: 19845

Drug Name

BETOPTIC S

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1989-12-29

19845 / 1 View Details

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

19845

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1989-12-29

Regulatory Status

RX

1984

17 Aug

Discontinued Application: 18762

Drug Name

BRETHAIRE

Product Number

1

Dosage Form

-

Strength

0.2MG/INH

Approval Date

1984-08-17

18762 / 1 View Details

Active Ingredient

TERBUTALINE SULFATE

Application Number

18762

Product Number

1

Dosage Form

-

Strength

0.2MG/INH

Approval Date

1984-08-17

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8319

Drug Name

BUTAZOLIDIN

Product Number

8

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

8319 / 8 View Details

Active Ingredient

PHENYLBUTAZONE

Application Number

8319

Product Number

8

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8319

Drug Name

BUTAZOLIDIN

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

8319 / 9 View Details

Active Ingredient

PHENYLBUTAZONE

Application Number

8319

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6620

Drug Name

CAFERGOT

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

1982-01-01

6620 / 1 View Details

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

6620

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9000

Drug Name

CAFERGOT

Product Number

2

Dosage Form

-

Strength

100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9000 / 2 View Details

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

9000

Product Number

2

Dosage Form

-

Strength

100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

28 Apr

Discontinued Application: 73677

Drug Name

CARBASTAT

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1995-04-28

73677 / 1 View Details

Active Ingredient

CARBACHOL

Application Number

73677

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1995-04-28

Regulatory Status

Discontinued

1993

24 Nov

Discontinued Application: 20142

Drug Name

CATAFLAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-11-24

20142 / 1 View Details

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

20142

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-11-24

Regulatory Status

Discontinued

1993

24 Nov

Discontinued Application: 20142

Drug Name

CATAFLAM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-11-24

20142 / 2 View Details

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

20142

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-11-24

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9282

Drug Name

CEDILANID-D

Product Number

2

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

9282 / 2 View Details

Active Ingredient

DESLANOSIDE

Application Number

9282

Product Number

2

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986

31 Oct

Discontinued Application: 18470

Drug Name

CIBACALCIN

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

1986-10-31

18470 / 1 View Details

Active Ingredient

CALCITONIN HUMAN

Application Number

18470

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

1986-10-31

Regulatory Status

Discontinued

2009

07 Apr

RX Application: 22268

Drug Name

COARTEM

Product Number

1

Dosage Form

-

Strength

20MG;120MG

Approval Date

2009-04-07

22268 / 1 View Details

Active Ingredient

ARTEMETHER; LUMEFANTRINE

Application Number

22268

Product Number

1

Dosage Form

-

Strength

20MG;120MG

Approval Date

2009-04-07

Regulatory Status

RX

-

Unclassified Application: 125504

Drug Name

COSENTYX

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

125504 / 1 View Details

Active Ingredient

SECUKINUMAB

Application Number

125504

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 761349

Drug Name

COSENTYX

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

761349 / 1 View Details

Active Ingredient

SECUKINUMAB

Application Number

761349

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 18202

Drug Name

CYTADREN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

18202 / 1 View Details

Active Ingredient

AMINOGLUTETHIMIDE

Application Number

18202

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984

29 Oct

Discontinued Application: 62544

Drug Name

DEXACIDIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-10-29

62544 / 1 View Details

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62544

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1984-10-29

Regulatory Status

Discontinued

1985

22 Feb

Discontinued Application: 62566

Drug Name

DEXACIDIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1985-02-22

62566 / 1 View Details

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62566

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1985-02-22

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16755

Drug Name

DIAPID

Product Number

1

Dosage Form

-

Strength

0.185MG/ML

Approval Date

1982-01-01

16755 / 1 View Details

Active Ingredient

LYPRESSIN

Application Number

16755

Product Number

1

Dosage Form

-

Strength

0.185MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996

23 Dec

Discontinued Application: 20665

Drug Name

DIOVAN

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1996-12-23

20665 / 1 View Details

Active Ingredient

VALSARTAN

Application Number

20665

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1996-12-23

Regulatory Status

Discontinued

1996

23 Dec

Discontinued Application: 20665

Drug Name

DIOVAN

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

1996-12-23

20665 / 2 View Details

Active Ingredient

VALSARTAN

Application Number

20665

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

1996-12-23

Regulatory Status

Discontinued

2001

18 Jul

RX Application: 21283

Drug Name

DIOVAN

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2001-07-18

21283 / 1 View Details

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2001-07-18

Regulatory Status

RX

2001

18 Jul

RX Application: 21283

Drug Name

DIOVAN

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2001-07-18

21283 / 2 View Details

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2001-07-18

Regulatory Status

RX

2001

18 Jul

RX Application: 21283

Drug Name

DIOVAN

Product Number

3

Dosage Form

-

Strength

320MG

Approval Date

2001-07-18

21283 / 3 View Details

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

3

Dosage Form

-

Strength

320MG

Approval Date

2001-07-18

Regulatory Status

RX

2002

14 Aug

RX Application: 21283

Drug Name

DIOVAN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2002-08-14

21283 / 4 View Details

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2002-08-14

Regulatory Status

RX

1998

06 Mar

RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

1998-03-06

20818 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

1998-03-06

Regulatory Status

RX

1998

06 Mar

RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

1998-03-06

20818 / 2 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

1998-03-06

Regulatory Status

RX

2002

17 Jan

RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

3

Dosage Form

-

Strength

25MG;160MG

Approval Date

2002-01-17

20818 / 3 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

3

Dosage Form

-

Strength

25MG;160MG

Approval Date

2002-01-17

Regulatory Status

RX

2006

28 Apr

RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

4

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2006-04-28

20818 / 4 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

4

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2006-04-28

Regulatory Status

RX

2006

28 Apr

RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2006-04-28

20818 / 5 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2006-04-28

Regulatory Status

RX

2019

13 Feb

RX Application: 208711

Drug Name

EGATEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-13

208711 / 1 View Details

Active Ingredient

TRICLABENDAZOLE

Application Number

208711

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-13

Regulatory Status

RX

1997

29 Dec

Discontinued Application: 20706

Drug Name

EMADINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-12-29

20706 / 1 View Details

Active Ingredient

EMEDASTINE DIFUMARATE

Application Number

20706

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-12-29

Regulatory Status

Discontinued

1984

30 Nov

Discontinued Application: 18885

Drug Name

EMBOLEX

Product Number

1

Dosage Form

-

Strength

0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML

Approval Date

1984-11-30

18885 / 1 View Details

Active Ingredient

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

Application Number

18885

Product Number

1

Dosage Form

-

Strength

0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML

Approval Date

1984-11-30

Regulatory Status

Discontinued

1984

30 Nov

Discontinued Application: 18885

Drug Name

EMBOLEX

Product Number

2

Dosage Form

-

Strength

0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML

Approval Date

1984-11-30

18885 / 2 View Details

Active Ingredient

DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

Application Number

18885

Product Number

2

Dosage Form

-

Strength

0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML

Approval Date

1984-11-30

Regulatory Status

Discontinued

2015

07 Jul

RX Application: 207620

Drug Name

ENTRESTO

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2015-07-07

207620 / 1 View Details

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2015-07-07

Regulatory Status

RX

2015

07 Jul

RX Application: 207620

Drug Name

ENTRESTO

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2015-07-07

207620 / 2 View Details

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2015-07-07

Regulatory Status

RX

2015

07 Jul

RX Application: 207620

Drug Name

ENTRESTO

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2015-07-07

207620 / 3 View Details

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2015-07-07

Regulatory Status

RX

2024

12 Apr

RX Application: 218591

Drug Name

ENTRESTO SPRINKLE

Product Number

1

Dosage Form

-

Strength

6MG;6MG

Approval Date

2024-04-12

218591 / 1 View Details

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

218591

Product Number

1

Dosage Form

-

Strength

6MG;6MG

Approval Date

2024-04-12

Regulatory Status

RX

2024

12 Apr

RX Application: 218591

Drug Name

ENTRESTO SPRINKLE

Product Number

2

Dosage Form

-

Strength

15MG;16MG

Approval Date

2024-04-12

218591 / 2 View Details

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

218591

Product Number

2

Dosage Form

-

Strength

15MG;16MG

Approval Date

2024-04-12

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

11793 / 5 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

11793 / 8 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

8

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11793

Drug Name

ESIDRIX

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

11793 / 9 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

11793

Product Number

9

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13553

Drug Name

ESIMIL

Product Number

1

Dosage Form

-

Strength

10MG;25MG

Approval Date

1982-01-01

13553 / 1 View Details

Active Ingredient

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

Application Number

13553

Product Number

1

Dosage Form

-

Strength

10MG;25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986

10 Sep

Discontinued Application: 19081

Drug Name

ESTRADERM

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1986-09-10

19081 / 2 View Details

Active Ingredient

ESTRADIOL

Application Number

19081

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

1986-09-10

Regulatory Status

Discontinued

1986

10 Sep

Discontinued Application: 19081

Drug Name

ESTRADERM

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1986-09-10

19081 / 3 View Details

Active Ingredient

ESTRADIOL

Application Number

19081

Product Number

3

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

1986-09-10

Regulatory Status

Discontinued

2000

21 Apr

Discontinued Application: 20823

Drug Name

EXELON

Product Number

3

Dosage Form

-

Strength

EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

20823 / 3 View Details

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

3

Dosage Form

-

Strength

EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000

21 Apr

Discontinued Application: 20823

Drug Name

EXELON

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2000-04-21

20823 / 4 View Details

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

4

Dosage Form

-

Strength

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

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000

21 Apr

Discontinued Application: 20823

Drug Name

EXELON

Product Number

5

Dosage Form

-

Strength

EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

20823 / 5 View Details

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

5

Dosage Form

-

Strength

EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000

21 Apr

Discontinued Application: 20823

Drug Name

EXELON

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2000-04-21

20823 / 6 View Details

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

20823

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2000-04-21

Regulatory Status

Discontinued

2000

21 Apr

Discontinued Application: 21025

Drug Name

EXELON

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2000-04-21

21025 / 1 View Details

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

21025

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2000-04-21

Regulatory Status

Discontinued

2007

20 Jun

RX Application: 21990

Drug Name

EXFORGE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2007-06-20

21990 / 2 View Details

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2007-06-20

Regulatory Status

RX

2007

20 Jun

RX Application: 21990

Drug Name

EXFORGE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2007-06-20

21990 / 3 View Details

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2007-06-20

Regulatory Status

RX

2007

20 Jun

RX Application: 21990

Drug Name

EXFORGE

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2007-06-20

21990 / 4 View Details

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2007-06-20

Regulatory Status

RX

2007

20 Jun

RX Application: 21990

Drug Name

EXFORGE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2007-06-20

21990 / 5 View Details

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2007-06-20

Regulatory Status

RX

2009

30 Apr

RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2009-04-30

22314 / 1 View Details

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2009-04-30

22314 / 2 View Details

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2009-04-30

22314 / 3 View Details

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2009-04-30

22314 / 4 View Details

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009

30 Apr

RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2009-04-30

22314 / 5 View Details

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2009-04-30

Regulatory Status

RX

2005

02 Nov

RX Application: 21882

Drug Name

EXJADE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2005-11-02

21882 / 1 View Details

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2005-11-02

Regulatory Status

RX

2005

02 Nov

RX Application: 21882

Drug Name

EXJADE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2005-11-02

21882 / 2 View Details

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2005-11-02

Regulatory Status

RX

2005

02 Nov

RX Application: 21882

Drug Name

EXJADE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2005-11-02

21882 / 3 View Details

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2005-11-02

Regulatory Status

RX

2023

05 Dec

RX Application: 218276

Drug Name

FABHALTA

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-12-05

218276 / 1 View Details

Active Ingredient

IPTACOPAN HYDROCHLORIDE

Application Number

218276

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-12-05

Regulatory Status

RX

1996

26 Apr

Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

20363 / 1 View Details

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-04-26

Regulatory Status

Discontinued

1994

29 Jun

Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-29

20363 / 2 View Details

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1994-06-29

Regulatory Status

Discontinued

1995

11 Dec

Discontinued Application: 20363

Drug Name

FAMVIR

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-11

20363 / 3 View Details

Active Ingredient

FAMCICLOVIR

Application Number

20363

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-12-11

Regulatory Status

Discontinued

1997

25 Jul

RX Application: 20726

Drug Name

FEMARA

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1997-07-25

20726 / 1 View Details

Active Ingredient

LETROZOLE

Application Number

20726

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1997-07-25

Regulatory Status

RX

1986

27 Feb

Discontinued Application: 70185

Drug Name

FLUOR-OP

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1986-02-27

70185 / 1 View Details

Active Ingredient

FLUOROMETHOLONE

Application Number

70185

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1986-02-27

Regulatory Status

Discontinued

1989

28 Jun

Discontinued Application: 72687

Drug Name

FOAMICON

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1989-06-28

72687 / 1 View Details

Active Ingredient

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

Application Number

72687

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1989-06-28

Regulatory Status

Discontinued

2001

16 Feb

Discontinued Application: 20831

Drug Name

FORADIL

Product Number

1

Dosage Form

-

Strength

0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-16

20831 / 1 View Details

Active Ingredient

FORMOTEROL FUMARATE

Application Number

20831

Product Number

1

Dosage Form

-

Strength

0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-16

Regulatory Status

Discontinued

-

Unclassified Application: 21279

Drug Name

FORADIL

Product Number

1

Dosage Form

-

Strength

0.012MG/INH

Approval Date

-

21279 / 1 View Details

Active Ingredient

FORMOTEROL FUMARATE

Application Number

21279

Product Number

1

Dosage Form

-

Strength

0.012MG/INH

Approval Date

-

Regulatory Status

Unclassified

2006

15 Dec

Discontinued Application: 21592

Drug Name

FORADIL CERTIHALER

Product Number

1

Dosage Form

-

Strength

0.0085MG/INH

Approval Date

2006-12-15

21592 / 1 View Details

Active Ingredient

FORMOTEROL FUMARATE

Application Number

21592

Product Number

1

Dosage Form

-

Strength

0.0085MG/INH

Approval Date

2006-12-15

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17869

Drug Name

FUNDUSCEIN-25

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17869 / 1 View Details

Active Ingredient

FLUORESCEIN SODIUM

Application Number

17869

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984

30 Mar

Discontinued Application: 62480

Drug Name

GENTACIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-03-30

62480 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

62480

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-03-30

Regulatory Status

Discontinued

1984

26 Jul

Discontinued Application: 62501

Drug Name

GENTACIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-07-26

62501 / 1 View Details

Active Ingredient

GENTAMICIN SULFATE

Application Number

62501

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1984-07-26

Regulatory Status

Discontinued

2010

21 Sep

RX Application: 22527

Drug Name

GILENYA

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2010-09-21

22527 / 1 View Details

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

22527

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2010-09-21

Regulatory Status

RX

2018

11 May

RX Application: 22527

Drug Name

GILENYA

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2018-05-11

22527 / 2 View Details

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

22527

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2018-05-11

Regulatory Status

RX

2001

10 May

Discontinued Application: 21335

Drug Name

GLEEVEC

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-05-10

21335 / 1 View Details

Active Ingredient

IMATINIB MESYLATE

Application Number

21335

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-05-10

Regulatory Status

Discontinued

2001

10 May

Discontinued Application: 21335

Drug Name

GLEEVEC

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2001-05-10

21335 / 2 View Details

Active Ingredient

IMATINIB MESYLATE

Application Number

21335

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2001-05-10

Regulatory Status

Discontinued

2003

18 Apr

RX Application: 21588

Drug Name

GLEEVEC

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-04-18

21588 / 1 View Details

Active Ingredient

IMATINIB MESYLATE

Application Number

21588

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-04-18

Regulatory Status

RX

2003

18 Apr

RX Application: 21588

Drug Name

GLEEVEC

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2003-04-18

21588 / 2 View Details

Active Ingredient

IMATINIB MESYLATE

Application Number

21588

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2003-04-18

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 6203

Drug Name

HEAVY SOLUTION NUPERCAINE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

6203 / 1 View Details

Active Ingredient

DIBUCAINE HYDROCHLORIDE

Application Number

6203

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9087

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

9087 / 1 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

9087

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9087

Drug Name

HYDERGINE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

9087 / 2 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

9087

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17993

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17993 / 1 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

17993

Product Number

1

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

1982

01 Jan

Discontinued Application: 17993

Drug Name

HYDERGINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17993 / 3 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

17993

Product Number

3

Dosage Form

-

Strength

0.5MG **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: 18418

Drug Name

HYDERGINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

18418 / 1 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

18418

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983

18 Jan

Discontinued Application: 18706

Drug Name

HYDERGINE LC

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1983-01-18

18706 / 1 View Details

Active Ingredient

ERGOLOID MESYLATES

Application Number

18706

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1983-01-18

Regulatory Status

Discontinued

-

Unclassified Application: 125319

Drug Name

ILARIS

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

-

125319 / 1 View Details

Active Ingredient

CANAKINUMAB

Application Number

125319

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 86765

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

86765 / 1 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

86765

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80751

Drug Name

INFLAMASE FORTE

Product Number

2

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1982-01-01

80751 / 2 View Details

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

80751

Product Number

2

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80751

Drug Name

INFLAMASE MILD

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1982-01-01

80751 / 1 View Details

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

80751

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80935

Drug Name

INH

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

80935 / 1 View Details

Active Ingredient

ISONIAZID

Application Number

80935

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12329

Drug Name

ISMELIN

Product Number

1

Dosage Form

-

Strength

EQ 10MG SULFATE

Approval Date

1982-01-01

12329 / 1 View Details

Active Ingredient

GUANETHIDINE MONOSULFATE

Application Number

12329

Product Number

1

Dosage Form

-

Strength

EQ 10MG SULFATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12329

Drug Name

ISMELIN

Product Number

2

Dosage Form

-

Strength

EQ 25MG SULFATE

Approval Date

1982-01-01

12329 / 2 View Details

Active Ingredient

GUANETHIDINE MONOSULFATE

Application Number

12329

Product Number

2

Dosage Form

-

Strength

EQ 25MG SULFATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2014

15 May

Discontinued Application: 204822

Drug Name

IZBA

Product Number

1

Dosage Form

-

Strength

0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-05-15

204822 / 1 View Details

Active Ingredient

TRAVOPROST

Application Number

204822

Product Number

1

Dosage Form

-

Strength

0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-05-15

Regulatory Status

Discontinued

2015

30 Mar

RX Application: 206910

Drug Name

JADENU

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2015-03-30

206910 / 1 View Details

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2015-03-30

Regulatory Status

RX

2015

30 Mar

RX Application: 206910

Drug Name

JADENU

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2015-03-30

206910 / 2 View Details

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2015-03-30

Regulatory Status

RX

2015

30 Mar

RX Application: 206910

Drug Name

JADENU

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2015-03-30

206910 / 3 View Details

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2015-03-30

Regulatory Status

RX

2017

18 May

RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2017-05-18

207968 / 1 View Details

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2017-05-18

Regulatory Status

RX

2017

18 May

RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-05-18

207968 / 2 View Details

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-05-18

Regulatory Status

RX

2017

18 May

RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2017-05-18

207968 / 3 View Details

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2017-05-18

Regulatory Status

RX

-

Unclassified Application: 125326

Drug Name

KESIMPTA

Product Number

2

Dosage Form

-

Strength

20MG/0.4ML

Approval Date

-

125326 / 2 View Details

Active Ingredient

OFATUMUMAB

Application Number

125326

Product Number

2

Dosage Form

-

Strength

20MG/0.4ML

Approval Date

-

Regulatory Status

Unclassified

2017

13 Mar

RX Application: 209092

Drug Name

KISQALI

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-03-13

209092 / 1 View Details

Active Ingredient

RIBOCICLIB SUCCINATE

Application Number

209092

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-03-13

Regulatory Status

RX

2017

04 May

RX Application: 209935

Drug Name

KISQALI FEMARA CO-PACK (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

2.5MG;EQ 200MG BASE

Approval Date

2017-05-04

209935 / 1 View Details

Active Ingredient

LETROZOLE; RIBOCICLIB SUCCINATE

Application Number

209935

Product Number

1

Dosage Form

-

Strength

2.5MG;EQ 200MG BASE

Approval Date

2017-05-04

Regulatory Status

RX

1992

30 Dec

Discontinued Application: 20192

Drug Name

LAMISIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-30

20192 / 1 View Details

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

20192

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-12-30

Regulatory Status

Discontinued

1996

10 May

Discontinued Application: 20539

Drug Name

LAMISIL

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

1996-05-10

20539 / 1 View Details

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

20539

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

1996-05-10

Regulatory Status

Discontinued

2007

28 Sep

Discontinued Application: 22071

Drug Name

LAMISIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/PACKET

Approval Date

2007-09-28

22071 / 1 View Details

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

22071

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/PACKET

Approval Date

2007-09-28

Regulatory Status

Discontinued

2007

28 Sep

Discontinued Application: 22071

Drug Name

LAMISIL

Product Number

2

Dosage Form

-

Strength

EQ 187.5MG BASE/PACKET

Approval Date

2007-09-28

22071 / 2 View Details

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

22071

Product Number

2

Dosage Form

-

Strength

EQ 187.5MG BASE/PACKET

Approval Date

2007-09-28

Regulatory Status

Discontinued

1986

15 Dec

Discontinued Application: 19500

Drug Name

LAMPRENE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-12-15

19500 / 1 View Details

Active Ingredient

CLOFAZIMINE

Application Number

19500

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1986-12-15

Regulatory Status

Discontinued

1986

15 Dec

Discontinued Application: 19500

Drug Name

LAMPRENE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1986-12-15

19500 / 2 View Details

Active Ingredient

CLOFAZIMINE

Application Number

19500

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1986-12-15

Regulatory Status

Discontinued

2021

22 Dec

RX Application: 214012

Drug Name

LEQVIO

Product Number

1

Dosage Form

-

Strength

EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Approval Date

2021-12-22

214012 / 1 View Details

Active Ingredient

INCLISIRAN SODIUM

Application Number

214012

Product Number

1

Dosage Form

-

Strength

EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Approval Date

2021-12-22

Regulatory Status

RX

1993

31 Dec

Discontinued Application: 20261

Drug Name

LESCOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-31

20261 / 1 View Details

Active Ingredient

FLUVASTATIN SODIUM

Application Number

20261

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-12-31

Regulatory Status

Discontinued

1993

31 Dec

Discontinued Application: 20261

Drug Name

LESCOL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-12-31

20261 / 2 View Details

Active Ingredient

FLUVASTATIN SODIUM

Application Number

20261

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1993-12-31

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17851

Drug Name

LIORESAL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17851 / 1 View Details

Active Ingredient

BACLOFEN

Application Number

17851

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

20 Jan

Discontinued Application: 17851

Drug Name

LIORESAL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-20

17851 / 3 View Details

Active Ingredient

BACLOFEN

Application Number

17851

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-20

Regulatory Status

Discontinued

1993

10 Nov

Discontinued Application: 20219

Drug Name

LIVOSTIN

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1993-11-10

20219 / 1 View Details

Active Ingredient

LEVOCABASTINE HYDROCHLORIDE

Application Number

20219

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1993-11-10

Regulatory Status

Discontinued

2022

23 Mar

RX Application: 215841

Drug Name

LOCAMETZ

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2022-03-23

215841 / 1 View Details

Active Ingredient

GALLIUM GA-68 GOZETOTIDE

Application Number

215841

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2022-03-23

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 16379

Drug Name

LOCORTEN

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1982-01-01

16379 / 1 View Details

Active Ingredient

FLUMETHASONE PIVALATE

Application Number

16379

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

31 Dec

Discontinued Application: 19451

Drug Name

LOPRESSIDONE

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-12-31

19451 / 1 View Details

Active Ingredient

CHLORTHALIDONE; METOPROLOL TARTRATE

Application Number

19451

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1987

31 Dec

Discontinued Application: 19451

Drug Name

LOPRESSIDONE

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-12-31

19451 / 2 View Details

Active Ingredient

CHLORTHALIDONE; METOPROLOL TARTRATE

Application Number

19451

Product Number

2

Dosage Form

-

Strength

25MG;200MG

Approval Date

1987-12-31

Regulatory Status

Discontinued

1984

30 Mar

Discontinued Application: 18704

Drug Name

LOPRESSOR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-03-30

18704 / 1 View Details

Active Ingredient

METOPROLOL TARTRATE

Application Number

18704

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1984-03-30

Regulatory Status

Discontinued

1989

27 Dec

Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

1

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

1989-12-27

19786 / 1 View Details

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

1

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989

27 Dec

Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

2

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

1989-12-27

19786 / 2 View Details

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

2

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989

27 Dec

Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

3

Dosage Form

-

Strength

EQ 300MG TARTRATE

Approval Date

1989-12-27

19786 / 3 View Details

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

3

Dosage Form

-

Strength

EQ 300MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1989

27 Dec

Discontinued Application: 19786

Drug Name

LOPRESSOR

Product Number

4

Dosage Form

-

Strength

EQ 400MG TARTRATE

Approval Date

1989-12-27

19786 / 4 View Details

Active Ingredient

METOPROLOL FUMARATE

Application Number

19786

Product Number

4

Dosage Form

-

Strength

EQ 400MG TARTRATE

Approval Date

1989-12-27

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

17543 / 1 View Details

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

17543 / 2 View Details

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

30 Sep

Discontinued Application: 17543

Drug Name

LUDIOMIL

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-09-30

17543 / 3 View Details

Active Ingredient

MAPROTILINE HYDROCHLORIDE

Application Number

17543

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-09-30

Regulatory Status

Discontinued

2019

26 Mar

RX Application: 209884

Drug Name

MAYZENT

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2019-03-26

209884 / 1 View Details

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2019-03-26

Regulatory Status

RX

2019

26 Mar

RX Application: 209884

Drug Name

MAYZENT

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-26

209884 / 2 View Details

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-26

Regulatory Status

RX

2021

24 Aug

RX Application: 209884

Drug Name

MAYZENT

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-08-24

209884 / 3 View Details

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-08-24

Regulatory Status

RX

2013

29 May

RX Application: 204114

Drug Name

MEKINIST

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2013-05-29

204114 / 1 View Details

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2013-05-29

Regulatory Status

RX

2013

29 May

Discontinued Application: 204114

Drug Name

MEKINIST

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-05-29

204114 / 2 View Details

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-05-29

Regulatory Status

Discontinued

2013

29 May

RX Application: 204114

Drug Name

MEKINIST

Product Number

3

Dosage Form

-

Strength

EQ 2MG

Approval Date

2013-05-29

204114 / 3 View Details

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

3

Dosage Form

-

Strength

EQ 2MG

Approval Date

2013-05-29

Regulatory Status

RX

2023

16 Mar

RX Application: 217513

Drug Name

MEKINIST

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2023-03-16

217513 / 1 View Details

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

217513

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2023-03-16

Regulatory Status

RX

-

Unclassified Application: 217513

Drug Name

MEKINIST

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

-

217513 / 2 View Details

Active Ingredient

TRAMETINIB

Application Number

217513

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 217513

Drug Name

MEKINIST

Product Number

3

Dosage Form

-

Strength

4.7MG

Approval Date

-

217513 / 3 View Details

Active Ingredient

TRAMETINIB

Application Number

217513

Product Number

3

Dosage Form

-

Strength

4.7MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 3 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 6 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

6

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 9 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

11

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 11 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

11

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

12

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 12 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

12

Dosage Form

-

Strength

30MG/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: 11808

Drug Name

MELLARIL

Product Number

15

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 15 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

15

Dosage Form

-

Strength

200MG **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: 11808

Drug Name

MELLARIL

Product Number

16

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11808 / 16 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

16

Dosage Form

-

Strength

15MG **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: 11808

Drug Name

MELLARIL

Product Number

17

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 17 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

17

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11808

Drug Name

MELLARIL

Product Number

18

Dosage Form

-

Strength

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

Approval Date

1982-01-01

11808 / 18 View Details

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

11808

Product Number

18

Dosage Form

-

Strength

100MG/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: 17923

Drug Name

MELLARIL-S

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17923 / 1 View Details

Active Ingredient

THIORIDAZINE

Application Number

17923

Product Number

1

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/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: 17923

Drug Name

MELLARIL-S

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17923 / 2 View Details

Active Ingredient

THIORIDAZINE

Application Number

17923

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE/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: 6008

Drug Name

MESANTOIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

6008 / 1 View Details

Active Ingredient

MEPHENYTOIN

Application Number

6008

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3240

Drug Name

METANDREN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

3240 / 1 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3240

Drug Name

METANDREN

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

3240 / 3 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3240

Drug Name

METANDREN

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

3240 / 4 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 3240

Drug Name

METANDREN

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

3240 / 5 View Details

Active Ingredient

METHYLTESTOSTERONE

Application Number

3240

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16211

Drug Name

MIOCHOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16211 / 1 View Details

Active Ingredient

ACETYLCHOLINE CHLORIDE

Application Number

16211

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004

27 Feb

RX Application: 50791

Drug Name

MYFORTIC

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2004-02-27

50791 / 1 View Details

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

50791

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2004-02-27

Regulatory Status

RX

2004

27 Feb

RX Application: 50791

Drug Name

MYFORTIC

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2004-02-27

50791 / 2 View Details

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

50791

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2004-02-27

Regulatory Status

RX

1995

14 Jul

RX Application: 50715

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-07-14

50715 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-07-14

Regulatory Status

RX

1995

14 Jul

RX Application: 50715

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-07-14

50715 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-07-14

Regulatory Status

RX

1995

14 Jul

Discontinued Application: 50715

Drug Name

NEORAL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-07-14

50715 / 3 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1995-07-14

Regulatory Status

Discontinued

1995

14 Jul

RX Application: 50716

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1995-07-14

50716 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50716

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1995-07-14

Regulatory Status

RX

-

Unclassified Application: 50735

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

50735 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50735

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50735

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

50735 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50735

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50736

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

50736 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50736

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50736

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

50736 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50736

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50737

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

50737 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50737

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50737

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

50737 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50737

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50738

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

50738 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50738

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 50738

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

50738 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50738

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

2016

01 Jun

RX Application: 208547

Drug Name

NETSPOT

Product Number

1

Dosage Form

-

Strength

2.1-5.5mCi/ML

Approval Date

2016-06-01

208547 / 1 View Details

Active Ingredient

GALLIUM DOTATATE GA-68

Application Number

208547

Product Number

1

Dosage Form

-

Strength

2.1-5.5mCi/ML

Approval Date

2016-06-01

Regulatory Status

RX

2009

25 Nov

Discontinued Application: 22470

Drug Name

NEXCEDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-11-25

22470 / 1 View Details

Active Ingredient

KETOPROFEN

Application Number

22470

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-11-25

Regulatory Status

Discontinued

1990

23 May

Discontinued Application: 19972

Drug Name

OCUPRESS

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-05-23

19972 / 1 View Details

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

19972

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-05-23

Regulatory Status

Discontinued

2008

15 Apr

Discontinued Application: 21861

Drug Name

PATANASE

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-04-15

21861 / 1 View Details

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

21861

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-04-15

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5914

Drug Name

PBZ

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

5914 / 2 View Details

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

5914

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5914

Drug Name

PBZ

Product Number

4

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML

Approval Date

1982-01-01

5914 / 4 View Details

Active Ingredient

TRIPELENNAMINE CITRATE

Application Number

5914

Product Number

4

Dosage Form

-

Strength

EQ 25MG HYDROCHLORIDE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 83149

Drug Name

PBZ

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83149 / 1 View Details

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

83149

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10533

Drug Name

PBZ-SR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

10533 / 1 View Details

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

10533

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 10533

Drug Name

PBZ-SR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

10533 / 2 View Details

Active Ingredient

TRIPELENNAMINE HYDROCHLORIDE

Application Number

10533

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 5151

Drug Name

PERCORTEN

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

5151 / 1 View Details

Active Ingredient

DESOXYCORTICOSTERONE ACETATE

Application Number

5151

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8822

Drug Name

PERCORTEN

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

8822 / 1 View Details

Active Ingredient

DESOXYCORTICOSTERONE PIVALATE

Application Number

8822

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2019

24 May

RX Application: 212526

Drug Name

PIQRAY

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-05-24

212526 / 1 View Details

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-05-24

Regulatory Status

RX

2019

24 May

RX Application: 212526

Drug Name

PIQRAY

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-05-24

212526 / 2 View Details

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-05-24

Regulatory Status

RX

2019

24 May

RX Application: 212526

Drug Name

PIQRAY

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2019-05-24

212526 / 3 View Details

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2019-05-24

Regulatory Status

RX

2022

23 Mar

RX Application: 215833

Drug Name

PLUVICTO

Product Number

1

Dosage Form

-

Strength

27mCi/ML

Approval Date

2022-03-23

215833 / 1 View Details

Active Ingredient

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Application Number

215833

Product Number

1

Dosage Form

-

Strength

27mCi/ML

Approval Date

2022-03-23

Regulatory Status

RX

1985

22 Feb

Discontinued Application: 6403

Drug Name

PRISCOLINE

Product Number

5

Dosage Form

-

Strength

25MG/ML

Approval Date

1985-02-22

6403 / 5 View Details

Active Ingredient

TOLAZOLINE HYDROCHLORIDE

Application Number

6403

Product Number

5

Dosage Form

-

Strength

25MG/ML

Approval Date

1985-02-22

Regulatory Status

Discontinued

2008

20 Nov

RX Application: 22291

Drug Name

PROMACTA

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2008-11-20

22291 / 1 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2008-11-20

Regulatory Status

RX

2008

20 Nov

RX Application: 22291

Drug Name

PROMACTA

Product Number

2

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2008-11-20

22291 / 2 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

2

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2008-11-20

Regulatory Status

RX

2009

08 Sep

RX Application: 22291

Drug Name

PROMACTA

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2009-09-08

22291 / 3 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2009-09-08

Regulatory Status

RX

2011

20 Oct

RX Application: 22291

Drug Name

PROMACTA

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2011-10-20

22291 / 4 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2011-10-20

Regulatory Status

RX

2012

16 Nov

Discontinued Application: 22291

Drug Name

PROMACTA

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2012-11-16

22291 / 5 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2012-11-16

Regulatory Status

Discontinued

2015

24 Aug

RX Application: 207027

Drug Name

PROMACTA KIT

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID/PACKET

Approval Date

2015-08-24

207027 / 1 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

207027

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID/PACKET

Approval Date

2015-08-24

Regulatory Status

RX

2018

27 Sep

RX Application: 207027

Drug Name

PROMACTA KIT

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG ACID/PACKET

Approval Date

2018-09-27

207027 / 2 View Details

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

207027

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG ACID/PACKET

Approval Date

2018-09-27

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 9215

Drug Name

RAUTENSIN

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

9215 / 1 View Details

Active Ingredient

ALSEROXYLON

Application Number

9215

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 8278

Drug Name

REGITINE

Product Number

3

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

8278 / 3 View Details

Active Ingredient

PHENTOLAMINE MESYLATE

Application Number

8278

Product Number

3

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

2025

30 Sep

RX Application: 218436

Drug Name

RHAPSIDO

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-30

218436 / 1 View Details

Active Ingredient

REMIBRUTINIB

Application Number

218436

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-30

Regulatory Status

RX

1982

30 Mar

Discontinued Application: 18029

Drug Name

RITALIN-SR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-03-30

18029 / 1 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

18029

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-03-30

Regulatory Status

Discontinued

2017

28 Apr

RX Application: 207997

Drug Name

RYDAPT

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-04-28

207997 / 1 View Details

Active Ingredient

MIDOSTAURIN

Application Number

207997

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-04-28

Regulatory Status

RX

1983

14 Nov

RX Application: 50573

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1983-11-14

50573 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50573

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1983-11-14

Regulatory Status

RX

1983

14 Nov

RX Application: 50574

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-14

50574 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50574

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-14

Regulatory Status

RX

1990

02 Mar

RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-03-02

50625 / 1 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-03-02

Regulatory Status

RX

1990

02 Mar

RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1990-03-02

50625 / 2 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1990-03-02

Regulatory Status

RX

1992

23 Nov

RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1992-11-23

50625 / 3 View Details

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1992-11-23

Regulatory Status

RX

1988

21 Oct

RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1988-10-21

19667 / 1 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1988

21 Oct

RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1988-10-21

19667 / 2 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1988

21 Oct

RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1988-10-21

19667 / 3 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1991

12 Jun

Discontinued Application: 19667

Drug Name

SANDOSTATIN

Product Number

4

Dosage Form

-

Strength

EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-06-12

19667 / 4 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

4

Dosage Form

-

Strength

EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-06-12

Regulatory Status

Discontinued

1991

12 Jun

Discontinued Application: 19667

Drug Name

SANDOSTATIN

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1991-06-12

19667 / 5 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

5

Dosage Form

-

Strength

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

Approval Date

1991-06-12

Regulatory Status

Discontinued

1998

25 Nov

RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

1998-11-25

21008 / 1 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

1998

25 Nov

RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1998-11-25

21008 / 2 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

1998

25 Nov

RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

1998-11-25

21008 / 3 View Details

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 17247

Drug Name

SANOREX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17247 / 1 View Details

Active Ingredient

MAZINDOL

Application Number

17247

Product Number

1

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

1982

01 Jan

Discontinued Application: 17247

Drug Name

SANOREX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17247 / 2 View Details

Active Ingredient

MAZINDOL

Application Number

17247

Product Number

2

Dosage Form

-

Strength

2MG **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: 12516

Drug Name

SANSERT

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

12516 / 1 View Details

Active Ingredient

METHYSERGIDE MALEATE

Application Number

12516

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2021

29 Oct

RX Application: 215358

Drug Name

SCEMBLIX

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-10-29

215358 / 1 View Details

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-10-29

Regulatory Status

RX

2021

29 Oct

RX Application: 215358

Drug Name

SCEMBLIX

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-10-29

215358 / 2 View Details

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-10-29

Regulatory Status

RX

2024

18 Apr

RX Application: 215358

Drug Name

SCEMBLIX

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-18

215358 / 3 View Details

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-18

Regulatory Status

RX

2015

29 Oct

Discontinued Application: 207923

Drug Name

SEEBRI NEOHALER

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH

Approval Date

2015-10-29

207923 / 1 View Details

Active Ingredient

GLYCOPYRROLATE

Application Number

207923

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH

Approval Date

2015-10-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12193

Drug Name

SER-AP-ES

Product Number

5

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

12193 / 5 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

12193

Product Number

5

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16774

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 1 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16774

Drug Name

SERENTIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 2 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

2

Dosage Form

-

Strength

EQ 25MG 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: 16774

Drug Name

SERENTIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 3 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

3

Dosage Form

-

Strength

EQ 50MG 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: 16774

Drug Name

SERENTIL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16774 / 4 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16774

Product Number

4

Dosage Form

-

Strength

EQ 100MG 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: 16775

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

16775 / 1 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16775

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16997

Drug Name

SERENTIL

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

16997 / 1 View Details

Active Ingredient

MESORIDAZINE BESYLATE

Application Number

16997

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

9115 / 1 View Details

Active Ingredient

RESERPINE

Application Number

9115

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

3

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

9115 / 3 View Details

Active Ingredient

RESERPINE

Application Number

9115

Product Number

3

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

9115 / 4 View Details

Active Ingredient

RESERPINE

Application Number

9115

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9115

Drug Name

SERPASIL

Product Number

5

Dosage Form

-

Strength

0.2MG/4ML

Approval Date

1982-01-01

9115 / 5 View Details

Active Ingredient

RESERPINE

Application Number

9115

Product Number

5

Dosage Form

-

Strength

0.2MG/4ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9434

Drug Name

SERPASIL

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

9434 / 2 View Details

Active Ingredient

RESERPINE

Application Number

9434

Product Number

2

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9296

Drug Name

SERPASIL-APRESOLINE

Product Number

2

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

1982-01-01

9296 / 2 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; RESERPINE

Application Number

9296

Product Number

2

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 9296

Drug Name

SERPASIL-APRESOLINE

Product Number

4

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

9296 / 4 View Details

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; RESERPINE

Application Number

9296

Product Number

4

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11878

Drug Name

SERPASIL-ESIDRIX #1

Product Number

3

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

11878 / 3 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

11878

Product Number

3

Dosage Form

-

Strength

25MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11878

Drug Name

SERPASIL-ESIDRIX #2

Product Number

5

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

11878 / 5 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

11878

Product Number

5

Dosage Form

-

Strength

50MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-

Unclassified Application: 103764

Drug Name

SIMULECT

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

103764 / 1 View Details

Active Ingredient

BASILIXIMAB

Application Number

103764

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 103764

Drug Name

SIMULECT

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

103764 / 2 View Details

Active Ingredient

BASILIXIMAB

Application Number

103764

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

1982

01 Jan

Discontinued Application: 17476

Drug Name

SLOW-K

Product Number

2

Dosage Form

-

Strength

8MEQ

Approval Date

1982-01-01

17476 / 2 View Details

Active Ingredient

POTASSIUM CHLORIDE

Application Number

17476

Product Number

2

Dosage Form

-

Strength

8MEQ

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000

22 Dec

Discontinued Application: 21204

Drug Name

STARLIX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2000-12-22

21204 / 1 View Details

Active Ingredient

NATEGLINIDE

Application Number

21204

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2000-12-22

Regulatory Status

Discontinued

2000

22 Dec

Discontinued Application: 21204

Drug Name

STARLIX

Product Number

2

Dosage Form

-

Strength

120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-12-22

21204 / 2 View Details

Active Ingredient

NATEGLINIDE

Application Number

21204

Product Number

2

Dosage Form

-

Strength

120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-12-22

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 80025

Drug Name

SULF-10

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

80025 / 1 View Details

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

80025

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

31 Oct

Discontinued Application: 89047

Drug Name

SULF-15

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1995-10-31

89047 / 1 View Details

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

89047

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1995-10-31

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18245

Drug Name

SYNTOCINON

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML

Approval Date

1982-01-01

18245 / 1 View Details

Active Ingredient

OXYTOCIN

Application Number

18245

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020

06 May

RX Application: 213591

Drug Name

TABRECTA

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-05-06

213591 / 1 View Details

Active Ingredient

CAPMATINIB HYDROCHLORIDE

Application Number

213591

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-05-06

Regulatory Status

RX

2020

06 May

RX Application: 213591

Drug Name

TABRECTA

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-05-06

213591 / 2 View Details

Active Ingredient

CAPMATINIB HYDROCHLORIDE

Application Number

213591

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-05-06

Regulatory Status

RX

2013

29 May

RX Application: 202806

Drug Name

TAFINLAR

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-29

202806 / 1 View Details

Active Ingredient

DABRAFENIB MESYLATE

Application Number

202806

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-29

Regulatory Status

RX

2013

29 May

RX Application: 202806

Drug Name

TAFINLAR

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-29

202806 / 2 View Details

Active Ingredient

DABRAFENIB MESYLATE

Application Number

202806

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-29

Regulatory Status

RX

2023

16 Mar

RX Application: 217514

Drug Name

TAFINLAR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-16

217514 / 1 View Details

Active Ingredient

DABRAFENIB MESYLATE

Application Number

217514

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-16

Regulatory Status

RX

-

Unclassified Application: 217514

Drug Name

TAFINLAR

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

217514 / 2 View Details

Active Ingredient

DABRAFENIB MESYLATE

Application Number

217514

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 217514

Drug Name

TAFINLAR

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

217514 / 3 View Details

Active Ingredient

DABRAFENIB MESYLATE

Application Number

217514

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

1982

03 Sep

Discontinued Application: 12542

Drug Name

TANDEARIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-09-03

12542 / 4 View Details

Active Ingredient

OXYPHENBUTAZONE

Application Number

12542

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-09-03

Regulatory Status

Discontinued

2007

29 Oct

RX Application: 22068

Drug Name

TASIGNA

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-10-29

22068 / 1 View Details

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-10-29

Regulatory Status

RX

2010

17 Jun

RX Application: 22068

Drug Name

TASIGNA

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-17

22068 / 2 View Details

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-17

Regulatory Status

RX

2018

22 Mar

RX Application: 22068

Drug Name

TASIGNA

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-03-22

22068 / 3 View Details

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-03-22

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 17661

Drug Name

TAVIST

Product Number

1

Dosage Form

-

Strength

2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17661 / 1 View Details

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

1

Dosage Form

-

Strength

2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

28 Jun

Discontinued Application: 18675

Drug Name

TAVIST

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

18675 / 1 View Details

Active Ingredient

CLEMASTINE FUMARATE

Application Number

18675

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

Regulatory Status

Discontinued

2001

01 Mar

Discontinued Application: 21082

Drug Name

TAVIST ALLERGY/SINUS/HEADACHE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 0.25MG BASE;30MG

Approval Date

2001-03-01

21082 / 1 View Details

Active Ingredient

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21082

Product Number

1

Dosage Form

-

Strength

500MG;EQ 0.25MG BASE;30MG

Approval Date

2001-03-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17661

Drug Name

TAVIST-1

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1982-01-01

17661 / 2 View Details

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

2

Dosage Form

-

Strength

1.34MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992

21 Aug

Discontinued Application: 17661

Drug Name

TAVIST-1

Product Number

3

Dosage Form

-

Strength

1.34MG

Approval Date

1992-08-21

17661 / 3 View Details

Active Ingredient

CLEMASTINE FUMARATE

Application Number

17661

Product Number

3

Dosage Form

-

Strength

1.34MG

Approval Date

1992-08-21

Regulatory Status

Discontinued

1982

01 Jan

RX Application: 16608

Drug Name

TEGRETOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

16608 / 1 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

16608

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 18281

Drug Name

TEGRETOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18281 / 1 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

18281

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987

18 Dec

RX Application: 18927

Drug Name

TEGRETOL

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1987-12-18

18927 / 1 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

18927

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1987-12-18

Regulatory Status

RX

1996

25 Mar

RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-03-25

20234 / 1 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-03-25

Regulatory Status

RX

1996

25 Mar

RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-03-25

20234 / 2 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-03-25

Regulatory Status

RX

1996

25 Mar

RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-03-25

20234 / 3 View Details

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-03-25

Regulatory Status

RX

2010

26 Aug

Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

22545 / 1 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010

26 Aug

Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

22545 / 2 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010

26 Aug

Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

22545 / 3 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE;EQ 5MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

2010

26 Aug

Discontinued Application: 22545

Drug Name

TEKAMLO

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

22545 / 4 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Application Number

22545

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE;EQ 10MG BASE

Approval Date

2010-08-26

Regulatory Status

Discontinued

1986

16 Apr

Discontinued Application: 19381

Drug Name

TEN-K

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-16

19381 / 1 View Details

Active Ingredient

POTASSIUM CHLORIDE

Application Number

19381

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

1986-04-16

Regulatory Status

Discontinued

1988

28 Sep

RX Application: 50616

Drug Name

TOBRADEX

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-09-28

50616 / 1 View Details

Active Ingredient

DEXAMETHASONE; TOBRAMYCIN

Application Number

50616

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-09-28

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 50541

Drug Name

TOBREX

Product Number

1

Dosage Form

-

Strength

0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

50541 / 1 View Details

Active Ingredient

TOBRAMYCIN

Application Number

50541

Product Number

1

Dosage Form

-

Strength

0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

RX Application: 50555

Drug Name

TOBREX

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1982-01-01

50555 / 1 View Details

Active Ingredient

TOBRAMYCIN

Application Number

50555

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1982-01-01

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 11838

Drug Name

TOFRANIL

Product Number

2

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

11838 / 2 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

11838

Product Number

2

Dosage Form

-

Strength

12.5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12753

Drug Name

TORECAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

12753 / 1 View Details

Active Ingredient

THIETHYLPERAZINE MALEATE

Application Number

12753

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 12754

Drug Name

TORECAN

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

12754 / 2 View Details

Active Ingredient

THIETHYLPERAZINE MALATE

Application Number

12754

Product Number

2

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13247

Drug Name

TORECAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

13247 / 1 View Details

Active Ingredient

THIETHYLPERAZINE MALEATE

Application Number

13247

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996

27 Feb

Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

1

Dosage Form

-

Strength

0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 1 View Details

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

1

Dosage Form

-

Strength

0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996

27 Feb

Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

2

Dosage Form

-

Strength

0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 2 View Details

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

2

Dosage Form

-

Strength

0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996

27 Feb

Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

3

Dosage Form

-

Strength

0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 3 View Details

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

3

Dosage Form

-

Strength

0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996

27 Feb

Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

4

Dosage Form

-

Strength

0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 4 View Details

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

4

Dosage Form

-

Strength

0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1996

27 Feb

Discontinued Application: 20144

Drug Name

TRANSDERM-NITRO

Product Number

5

Dosage Form

-

Strength

0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

20144 / 5 View Details

Active Ingredient

NITROGLYCERIN

Application Number

20144

Product Number

5

Dosage Form

-

Strength

0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-02-27

Regulatory Status

Discontinued

1983

28 Dec

Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-12-28

18166 / 1 View Details

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983

28 Dec

Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-12-28

18166 / 2 View Details

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983

28 Dec

Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1983-12-28

18166 / 3 View Details

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1983

28 Dec

Discontinued Application: 18166

Drug Name

TRASICOR

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

1983-12-28

18166 / 4 View Details

Active Ingredient

OXPRENOLOL HYDROCHLORIDE

Application Number

18166

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

1983-12-28

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13420

Drug Name

TREST

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

13420 / 1 View Details

Active Ingredient

METHIXENE HYDROCHLORIDE

Application Number

13420

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18115

Drug Name

TRIAMINIC-12

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1982-01-01

18115 / 1 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

Application Number

18115

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997

09 Sep

Discontinued Application: 74857

Drug Name

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-09-09

74857 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; TRIAMTERENE

Application Number

74857

Product Number

1

Dosage Form

-

Strength

25MG;37.5MG

Approval Date

1997-09-09

Regulatory Status

Discontinued

2000

14 Jan

RX Application: 21014

Drug Name

TRILEPTAL

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2000-01-14

21014 / 1 View Details

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2000-01-14

Regulatory Status

RX

2000

14 Jan

RX Application: 21014

Drug Name

TRILEPTAL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-01-14

21014 / 2 View Details

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-01-14

Regulatory Status

RX

2000

14 Jan

RX Application: 21014

Drug Name

TRILEPTAL

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2000-01-14

21014 / 3 View Details

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2000-01-14

Regulatory Status

RX

2001

25 May

RX Application: 21285

Drug Name

TRILEPTAL

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2001-05-25

21285 / 1 View Details

Active Ingredient

OXCARBAZEPINE

Application Number

21285

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2001-05-25

Regulatory Status

RX

2007

13 Mar

RX Application: 22059

Drug Name

TYKERB

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-03-13

22059 / 1 View Details

Active Ingredient

LAPATINIB DITOSYLATE

Application Number

22059

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-03-13

Regulatory Status

RX

2006

25 Oct

Discontinued Application: 22011

Drug Name

TYZEKA

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-10-25

22011 / 1 View Details

Active Ingredient

TELBIVUDINE

Application Number

22011

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-10-25

Regulatory Status

Discontinued

2009

28 Apr

Discontinued Application: 22154

Drug Name

TYZEKA

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2009-04-28

22154 / 1 View Details

Active Ingredient

TELBIVUDINE

Application Number

22154

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2009-04-28

Regulatory Status

Discontinued

2015

29 Oct

Discontinued Application: 207930

Drug Name

UTIBRON NEOHALER

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH;27.5MCG/INH

Approval Date

2015-10-29

207930 / 1 View Details

Active Ingredient

GLYCOPYRROLATE; INDACATEROL MALEATE

Application Number

207930

Product Number

1

Dosage Form

-

Strength

15.6MCG/INH;27.5MCG/INH

Approval Date

2015-10-29

Regulatory Status

Discontinued

2009

16 Sep

Discontinued Application: 22217

Drug Name

VALTURNA

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;160MG

Approval Date

2009-09-16

22217 / 1 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; VALSARTAN

Application Number

22217

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE;160MG

Approval Date

2009-09-16

Regulatory Status

Discontinued

2009

16 Sep

Discontinued Application: 22217

Drug Name

VALTURNA

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;320MG

Approval Date

2009-09-16

22217 / 2 View Details

Active Ingredient

ALISKIREN HEMIFUMARATE; VALSARTAN

Application Number

22217

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE;320MG

Approval Date

2009-09-16

Regulatory Status

Discontinued

2025

02 Apr

RX Application: 219208

Drug Name

VANRAFIA

Product Number

1

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-04-02

219208 / 1 View Details

Active Ingredient

ATRASENTAN HYDROCHLORIDE

Application Number

219208

Product Number

1

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-04-02

Regulatory Status

RX

1988

26 Aug

Discontinued Application: 18988

Drug Name

VASOCIDIN

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-08-26

18988 / 1 View Details

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Application Number

18988

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-08-26

Regulatory Status

Discontinued

1984

05 Oct

Discontinued Application: 88791

Drug Name

VASOCIDIN

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-10-05

88791 / 1 View Details

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88791

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1984-10-05

Regulatory Status

Discontinued

1983

24 Mar

Discontinued Application: 80235

Drug Name

VASOCON

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1983-03-24

80235 / 2 View Details

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

80235

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1983-03-24

Regulatory Status

Discontinued

1994

11 Jul

Discontinued Application: 18746

Drug Name

VASOCON-A

Product Number

2

Dosage Form

-

Strength

0.5%;0.05%

Approval Date

1994-07-11

18746 / 2 View Details

Active Ingredient

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE

Application Number

18746

Product Number

2

Dosage Form

-

Strength

0.5%;0.05%

Approval Date

1994-07-11

Regulatory Status

Discontinued

2022

05 Apr

RX Application: 215039

Drug Name

VIJOICE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-04-05

215039 / 1 View Details

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-04-05

Regulatory Status

RX

2022

05 Apr

RX Application: 215039

Drug Name

VIJOICE

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2022-04-05

215039 / 2 View Details

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2022-04-05

Regulatory Status

RX

2022

05 Apr

RX Application: 215039

Drug Name

VIJOICE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2022-04-05

215039 / 3 View Details

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2022-04-05

Regulatory Status

RX

2024

24 Apr

RX Application: 218466

Drug Name

VIJOICE

Product Number

1

Dosage Form

-

Strength

50MG/PACKET

Approval Date

2024-04-24

218466 / 1 View Details

Active Ingredient

ALPELISIB

Application Number

218466

Product Number

1

Dosage Form

-

Strength

50MG/PACKET

Approval Date

2024-04-24

Regulatory Status

RX

1987

22 Jul

Discontinued Application: 18872

Drug Name

VISKAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;5MG

Approval Date

1987-07-22

18872 / 1 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; PINDOLOL

Application Number

18872

Product Number

1

Dosage Form

-

Strength

25MG;5MG

Approval Date

1987-07-22

Regulatory Status

Discontinued

1987

22 Jul

Discontinued Application: 18872

Drug Name

VISKAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;10MG

Approval Date

1987-07-22

18872 / 2 View Details

Active Ingredient

HYDROCHLOROTHIAZIDE; PINDOLOL

Application Number

18872

Product Number

2

Dosage Form

-

Strength

25MG;10MG

Approval Date

1987-07-22

Regulatory Status

Discontinued

1982

03 Sep

Discontinued Application: 18285

Drug Name

VISKEN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-09-03

18285 / 1 View Details

Active Ingredient

PINDOLOL

Application Number

18285

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-09-03

Regulatory Status

Discontinued

1982

03 Sep

Discontinued Application: 18285

Drug Name

VISKEN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-09-03

18285 / 2 View Details

Active Ingredient

PINDOLOL

Application Number

18285

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-09-03

Regulatory Status

Discontinued

1998

26 Aug

Discontinued Application: 20961

Drug Name

VITRAVENE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

6.6MG/ML

Approval Date

1998-08-26

20961 / 1 View Details

Active Ingredient

FOMIVIRSEN SODIUM

Application Number

20961

Product Number

1

Dosage Form

-

Strength

6.6MG/ML

Approval Date

1998-08-26

Regulatory Status

Discontinued

-

Unclassified Application: 21167

Drug Name

VIVELLE

Product Number

1

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

-

21167 / 1 View Details

Active Ingredient

ESTRADIOL

Application Number

21167

Product Number

1

Dosage Form

-

Strength

0.0375MG/24HR

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21167

Drug Name

VIVELLE

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

-

21167 / 2 View Details

Active Ingredient

ESTRADIOL

Application Number

21167

Product Number

2

Dosage Form

-

Strength

0.05MG/24HR

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21167

Drug Name

VIVELLE

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

-

21167 / 3 View Details

Active Ingredient

ESTRADIOL

Application Number

21167

Product Number

3

Dosage Form

-

Strength

0.075MG/24HR

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21167

Drug Name

VIVELLE

Product Number

4

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

-

21167 / 4 View Details

Active Ingredient

ESTRADIOL

Application Number

21167

Product Number

4

Dosage Form

-

Strength

0.1MG/24HR

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 21167

Drug Name

VIVELLE

Product Number

5

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

-

21167 / 5 View Details

Active Ingredient

ESTRADIOL

Application Number

21167

Product Number

5

Dosage Form

-

Strength

0.025MG/24HR

Approval Date

-

Regulatory Status

Unclassified

1988

28 Jul

Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 1 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1988

28 Jul

Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 2 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1988

28 Jul

Discontinued Application: 19201

Drug Name

VOLTAREN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-07-28

19201 / 3 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

19201

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-07-28

Regulatory Status

Discontinued

1991

28 Mar

Discontinued Application: 20037

Drug Name

VOLTAREN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1991-03-28

20037 / 1 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

20037

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1991-03-28

Regulatory Status

Discontinued

1996

08 Mar

Discontinued Application: 20254

Drug Name

VOLTAREN-XR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-03-08

20254 / 1 View Details

Active Ingredient

DICLOFENAC SODIUM

Application Number

20254

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-03-08

Regulatory Status

Discontinued

2009

19 Oct

RX Application: 22465

Drug Name

VOTRIENT

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2009-10-19

22465 / 1 View Details

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

22465

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2009-10-19

Regulatory Status

RX

2009

19 Oct

Discontinued Application: 22465

Drug Name

VOTRIENT

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-19

22465 / 2 View Details

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

22465

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-19

Regulatory Status

Discontinued

2001

20 Aug

Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-08-20

21223 / 1 View Details

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-08-20

Regulatory Status

Discontinued

2003

07 Mar

Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-03-07

21223 / 2 View Details

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-03-07

Regulatory Status

Discontinued

2011

17 Jun

Discontinued Application: 21223

Drug Name

ZOMETA

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-17

21223 / 3 View Details

Active Ingredient

ZOLEDRONIC ACID

Application Number

21223

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2011-06-17

Regulatory Status

Discontinued

-

Unclassified Application: 21386

Drug Name

ZOMETA

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

-

21386 / 1 View Details

Active Ingredient

ZOLEDRONIC ACID

Application Number

21386

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

-

Regulatory Status

Unclassified

2010

20 Apr

RX Application: 21560

Drug Name

ZORTRESS

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-04-20

21560 / 1 View Details

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-04-20

Regulatory Status

RX

2010

20 Apr

RX Application: 21560

Drug Name

ZORTRESS

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-04-20

21560 / 2 View Details

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-04-20

Regulatory Status

RX

2010

20 Apr

RX Application: 21560

Drug Name

ZORTRESS

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-20

21560 / 3 View Details

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-20

Regulatory Status

RX

2018

10 Aug

RX Application: 21560

Drug Name

ZORTRESS

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2018-08-10

21560 / 4 View Details

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2018-08-10

Regulatory Status

RX

2014

29 Apr

Discontinued Application: 205755

Drug Name

ZYKADIA

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-04-29

205755 / 1 View Details

Active Ingredient

CERITINIB

Application Number

205755

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-04-29

Regulatory Status

Discontinued

2019

18 Mar

RX Application: 211225

Drug Name

ZYKADIA

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-03-18

211225 / 1 View Details

Active Ingredient

CERITINIB

Application Number

211225

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-03-18

Regulatory Status

RX

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