Padagis
FDA Approved Drugs

Padagis

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued
  • Total Records 104
  • Latest Approval Date Apr 03, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
104
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Discontinued
40
View
RX
64
View
Company Overview

Company

Padagis

Country

Israel

Website

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Company Snapshot

Padagis

Zvi Bornstein str. PO Box: 80500 Old Industrial Park, Yerucham 16

Israel

padagis.com/ View on Map
FDA Approved Drug Records ( 104 records )
2020
24 Feb
RX Application: 203760

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2020-02-24

203760 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

203760

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

Approval Date

2020-02-24

Regulatory Status

RX

2017
17 Mar
Discontinued Application: 202609

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2017-03-17

202609 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

202609

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2017-03-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61212

Drug Name

BACITRACIN

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1982-01-01

61212 / 1

Active Ingredient

BACITRACIN

Application Number

61212

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
27 Feb
Discontinued Application: 65022

Drug Name

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

2002-02-27

65022 / 1

Active Ingredient

BACITRACIN ZINC; POLYMYXIN B SULFATE

Application Number

65022

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

2002-02-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62166

Drug Name

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

Product Number

2

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

62166 / 2

Active Ingredient

BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62166

Product Number

2

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
31 Jan
RX Application: 72538

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

72538 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

72538

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

Regulatory Status

RX

2017
09 Nov
Discontinued Application: 206118

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2017-11-09

206118 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

206118

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2017-11-09

Regulatory Status

Discontinued

2023
28 Jul
Discontinued Application: 211914

Drug Name

BRINZOLAMIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-07-28

211914 / 1

Active Ingredient

BRINZOLAMIDE

Application Number

211914

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-07-28

Regulatory Status

Discontinued

2008
01 Oct
RX Application: 77646

Drug Name

BROMOCRIPTINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2008-10-01

77646 / 1

Active Ingredient

BROMOCRIPTINE MESYLATE

Application Number

77646

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2008-10-01

Regulatory Status

RX

2014
15 Jul
RX Application: 205292

Drug Name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2014-07-15

205292 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

205292

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2014-07-15

Regulatory Status

RX

1997
07 Feb
Discontinued Application: 19881

Drug Name

BUTOCONAZOLE NITRATE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-02-07

19881 / 1

Active Ingredient

BUTOCONAZOLE NITRATE

Application Number

19881

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-02-07

Regulatory Status

Discontinued

2011
13 Apr
Discontinued Application: 91561

Drug Name

CALCIUM ACETATE

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2011-04-13

91561 / 1

Active Ingredient

CALCIUM ACETATE

Application Number

91561

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2011-04-13

Regulatory Status

Discontinued

2002
04 Dec
Discontinued Application: 50788

Drug Name

CENTANY

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2002-12-04

50788 / 1

Active Ingredient

MUPIROCIN

Application Number

50788

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2002-12-04

Regulatory Status

Discontinued

2008
17 Jun
RX Application: 78398

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-17

78398 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78398

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-17

Regulatory Status

RX

2007
18 Sep
RX Application: 77623

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

77623 / 1

Active Ingredient

CICLOPIROX

Application Number

77623

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

Regulatory Status

RX

2009
07 Jan
RX Application: 78266

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2009-01-07

78266 / 1

Active Ingredient

CICLOPIROX

Application Number

78266

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2009-01-07

Regulatory Status

RX

2010
16 Feb
RX Application: 78594

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-02-16

78594 / 1

Active Ingredient

CICLOPIROX

Application Number

78594

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-02-16

Regulatory Status

RX

1992
30 Sep
Discontinued Application: 63329

Drug Name

CLINDA-DERM

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1992-09-30

63329 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

63329

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1992-09-30

Regulatory Status

Discontinued

2010
07 Jul
Discontinued Application: 90902

Drug Name

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/5ML

Approval Date

2010-07-07

90902 / 1

Active Ingredient

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Application Number

90902

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/5ML

Approval Date

2010-07-07

Regulatory Status

Discontinued

1995
30 Nov
RX Application: 64050

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1995-11-30

64050 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

64050

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1995-11-30

Regulatory Status

RX

2000
25 May
RX Application: 65049

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2000-05-25

65049 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

65049

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2000-05-25

Regulatory Status

RX

2004
30 Nov
RX Application: 50793

Drug Name

CLINDESSE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2004-11-30

50793 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

50793

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2004-11-30

Regulatory Status

RX

1997
31 Oct
RX Application: 75027

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-10-31

75027 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75027

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-10-31

Regulatory Status

RX

2011
16 Jun
Discontinued Application: 90898

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-06-16

90898 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

90898

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-06-16

Regulatory Status

Discontinued

2005
28 Oct
RX Application: 76763

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-10-28

76763 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

76763

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-10-28

Regulatory Status

RX

2000
28 Jun
RX Application: 40246

Drug Name

COMPRO

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2000-06-28

40246 / 1

Active Ingredient

PROCHLORPERAZINE

Application Number

40246

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2000-06-28

Regulatory Status

RX

2003
07 Oct
Discontinued Application: 65151

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2003-10-07

65151 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65151

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2003-10-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17010

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17010 / 1

Active Ingredient

DESONIDE

Application Number

17010

Product Number

1

Dosage Form

-

Strength

0.05% **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: 17426

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

17426 / 1

Active Ingredient

DESONIDE

Application Number

17426

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

Regulatory Status

RX

2006
09 Jan
Discontinued Application: 77552

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2006-01-09

77552 / 1

Active Ingredient

DESOXIMETASONE

Application Number

77552

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2006-01-09

Regulatory Status

Discontinued

2003
28 Apr
Discontinued Application: 40475

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-04-28

40475 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

40475

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-04-28

Regulatory Status

Discontinued

2020
16 Dec
Discontinued Application: 211851

Drug Name

EFINACONAZOLE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2020-12-16

211851 / 1

Active Ingredient

EFINACONAZOLE

Application Number

211851

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2020-12-16

Regulatory Status

Discontinued

2001
02 Oct
RX Application: 21324

Drug Name

ENTOCORT EC

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2001-10-02

21324 / 1

Active Ingredient

BUDESONIDE

Application Number

21324

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2001-10-02

Regulatory Status

RX

1983
26 Sep
Discontinued Application: 62447

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-09-26

62447 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62447

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-09-26

Regulatory Status

Discontinued

1991
11 Jan
RX Application: 63038

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1991-01-11

63038 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

63038

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1991-01-11

Regulatory Status

RX

1993
29 Jan
RX Application: 63211

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1993-01-29

63211 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

63211

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1993-01-29

Regulatory Status

RX

1996
03 Jul
RX Application: 64126

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-07-03

64126 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

64126

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-07-03

Regulatory Status

RX

2026
02 Feb
Discontinued Application: 215096

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.06% (1.25GM/ACTIVATION)

Approval Date

2026-02-02

215096 / 1

Active Ingredient

ESTRADIOL

Application Number

215096

Product Number

1

Dosage Form

-

Strength

0.06% (1.25GM/ACTIVATION)

Approval Date

2026-02-02

Regulatory Status

Discontinued

2007
27 Jul
RX Application: 22014

Drug Name

EVAMIST

Product Number

1

Dosage Form

-

Strength

1.53MG/SPRAY

Approval Date

2007-07-27

22014 / 1

Active Ingredient

ESTRADIOL

Application Number

22014

Product Number

1

Dosage Form

-

Strength

1.53MG/SPRAY

Approval Date

2007-07-27

Regulatory Status

RX

2004
16 Dec
RX Application: 76831

Drug Name

FLAVOXATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-12-16

76831 / 1

Active Ingredient

FLAVOXATE HYDROCHLORIDE

Application Number

76831

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-12-16

Regulatory Status

RX

2018
19 Jun
RX Application: 209030

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-06-19

209030 / 1

Active Ingredient

FLUOCINONIDE

Application Number

209030

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-06-19

Regulatory Status

RX

1982
01 Jan
RX Application: 62307

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

62307 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62307

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-01-01

Regulatory Status

RX

1982
18 Feb
RX Application: 62351

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-02-18

62351 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62351

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1982-02-18

Regulatory Status

RX

2004
30 Jan
Discontinued Application: 65121

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

2004-01-30

65121 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

65121

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

2004-01-30

Regulatory Status

Discontinued

2026
03 Apr
Discontinued Application: 214448

Drug Name

GLYCOPYRRONIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.4% BASE

Approval Date

2026-04-03

214448 / 1

Active Ingredient

GLYCOPYRRONIUM TOSYLATE

Application Number

214448

Product Number

1

Dosage Form

-

Strength

EQ 2.4% BASE

Approval Date

2026-04-03

Regulatory Status

Discontinued

2017
15 Feb
Discontinued Application: 205731

Drug Name

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

2017-02-15

205731 / 1

Active Ingredient

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Application Number

205731

Product Number

1

Dosage Form

-

Strength

1.5MG/5ML;5MG/5ML

Approval Date

2017-02-15

Regulatory Status

Discontinued

2014
29 Apr
Discontinued Application: 204658

Drug Name

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML;60MG/5ML

Approval Date

2014-04-29

204658 / 1

Active Ingredient

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

204658

Product Number

1

Dosage Form

-

Strength

5MG/5ML;60MG/5ML

Approval Date

2014-04-29

Regulatory Status

Discontinued

2014
29 Apr
Discontinued Application: 204627

Drug Name

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML;60MG/5ML

Approval Date

2014-04-29

204627 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

204627

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML;60MG/5ML

Approval Date

2014-04-29

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 85025

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

85025 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85025

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85027

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

85027 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85027

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

Regulatory Status

RX

2015
06 Apr
RX Application: 204278

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2015-04-06

204278 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

204278

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2015-04-06

Regulatory Status

RX

2015
06 Apr
RX Application: 204278

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2015-04-06

204278 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

204278

Product Number

2

Dosage Form

-

Strength

12MG

Approval Date

2015-04-06

Regulatory Status

RX

2015
06 Apr
RX Application: 204278

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2015-04-06

204278 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

204278

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2015-04-06

Regulatory Status

RX

2017
20 Sep
RX Application: 204278

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2017-09-20

204278 / 4

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

204278

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2017-09-20

Regulatory Status

RX

2004
23 Sep
RX Application: 76925

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2004-09-23

76925 / 1

Active Ingredient

IBUPROFEN

Application Number

76925

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2004-09-23

Regulatory Status

RX

2021
17 Nov
Discontinued Application: 215185

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2021-11-17

215185 / 1

Active Ingredient

KETOCONAZOLE

Application Number

215185

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2021-11-17

Regulatory Status

Discontinued

2011
07 Nov
RX Application: 91263

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2011-11-07

91263 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

91263

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2011-11-07

Regulatory Status

RX

2021
27 Jul
RX Application: 212482

Drug Name

LIDOCAINE AND PRILOCAINE

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2021-07-27

212482 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

212482

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2021-07-27

Regulatory Status

RX

2024
10 Jul
RX Application: 215203

Drug Name

LOTEPREDNOL ETABONATE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2024-07-10

215203 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

215203

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

2024-07-10

Regulatory Status

RX

2025
29 Jan
RX Application: 215204

Drug Name

LOTEPREDNOL ETABONATE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-01-29

215204 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

215204

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2025-01-29

Regulatory Status

RX

1982
01 Jan
RX Application: 18200

Drug Name

MIDAMOR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

18200 / 1

Active Ingredient

AMILORIDE HYDROCHLORIDE

Application Number

18200

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

2005
02 May
RX Application: 76379

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2005-05-02

76379 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

76379

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2005-05-02

Regulatory Status

RX

2002
18 Mar
RX Application: 76067

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2002-03-18

76067 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

76067

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2002-03-18

Regulatory Status

RX

2012
06 Aug
Discontinued Application: 201574

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2012-08-06

201574 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

201574

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2012-08-06

Regulatory Status

Discontinued

2010
08 Jul
Discontinued Application: 91326

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-08

91326 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91326

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-08

Regulatory Status

Discontinued

2010
08 Jul
Discontinued Application: 91326

Drug Name

NARATRIPTAN

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-08

91326 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91326

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60764

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Product Number

2

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

60764 / 2

Active Ingredient

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

60764

Product Number

2

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

Discontinued

1989
31 Jul
Discontinued Application: 62938

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-07-31

62938 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62938

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1989-07-31

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 62225

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-01-01

62225 / 1

Active Ingredient

NYSTATIN

Application Number

62225

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

RX

1984
13 Feb
RX Application: 62472

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1984-02-13

62472 / 1

Active Ingredient

NYSTATIN

Application Number

62472

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1984-02-13

Regulatory Status

RX

1996
16 Aug
RX Application: 64118

Drug Name

NYSTOP

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1996-08-16

64118 / 1

Active Ingredient

NYSTATIN

Application Number

64118

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1996-08-16

Regulatory Status

RX

2004
16 Nov
Discontinued Application: 76746

Drug Name

PILOCARPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-11-16

76746 / 1

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

76746

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-11-16

Regulatory Status

Discontinued

2002
29 Jan
RX Application: 75600

Drug Name

PODOFILOX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2002-01-29

75600 / 1

Active Ingredient

PODOFILOX

Application Number

75600

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2002-01-29

Regulatory Status

RX

2023
22 Nov
RX Application: 211871

Drug Name

PODOFILOX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-22

211871 / 1

Active Ingredient

PODOFILOX

Application Number

211871

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-22

Regulatory Status

RX

2011
18 May
Discontinued Application: 200185

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2011-05-18

200185 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

200185

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2011-05-18

Regulatory Status

Discontinued

2011
18 May
Discontinued Application: 200185

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2011-05-18

200185 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

200185

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2011-05-18

Regulatory Status

Discontinued

2015
05 Nov
RX Application: 205993

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-11-05

205993 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

205993

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2015-11-05

Regulatory Status

RX

2015
05 Nov
RX Application: 205993

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-11-05

205993 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

205993

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2015-11-05

Regulatory Status

RX

2013
17 Jul
Discontinued Application: 201189

Drug Name

REPAGLINIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-07-17

201189 / 1

Active Ingredient

REPAGLINIDE

Application Number

201189

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-07-17

Regulatory Status

Discontinued

2014
22 Jan
Discontinued Application: 201189

Drug Name

REPAGLINIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2014-01-22

201189 / 2

Active Ingredient

REPAGLINIDE

Application Number

201189

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2014-01-22

Regulatory Status

Discontinued

2014
22 Jan
Discontinued Application: 201189

Drug Name

REPAGLINIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2014-01-22

201189 / 3

Active Ingredient

REPAGLINIDE

Application Number

201189

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2014-01-22

Regulatory Status

Discontinued

2015
30 Jan
RX Application: 78830

Drug Name

SCOPOLAMINE

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

2015-01-30

78830 / 1

Active Ingredient

SCOPOLAMINE

Application Number

78830

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

2015-01-30

Regulatory Status

RX

1991
10 Jan
RX Application: 89996

Drug Name

SELENIUM SULFIDE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1991-01-10

89996 / 1

Active Ingredient

SELENIUM SULFIDE

Application Number

89996

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1991-01-10

Regulatory Status

RX

1985
25 Nov
Discontinued Application: 89066

Drug Name

STIE-CORT

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1985-11-25

89066 / 1

Active Ingredient

HYDROCORTISONE

Application Number

89066

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1985-11-25

Regulatory Status

Discontinued

1985
26 Nov
RX Application: 89074

Drug Name

STIE-CORT

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1985-11-26

89074 / 1

Active Ingredient

HYDROCORTISONE

Application Number

89074

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1985-11-26

Regulatory Status

RX

2009
23 Mar
RX Application: 78649

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2009-03-23

78649 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

78649

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2009-03-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80029

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

80029 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

80029

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
13 Oct
Discontinued Application: 211848

Drug Name

TAVABOROLE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-10-13

211848 / 1

Active Ingredient

TAVABOROLE

Application Number

211848

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-10-13

Regulatory Status

Discontinued

2005
31 Jan
RX Application: 40530

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2005-01-31

40530 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

40530

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2005-01-31

Regulatory Status

RX

2022
11 Feb
RX Application: 212715

Drug Name

TOBRAMYCIN AND DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

2022-02-11

212715 / 1

Active Ingredient

DEXAMETHASONE; TOBRAMYCIN

Application Number

212715

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

2022-02-11

Regulatory Status

RX

1998
24 Dec
RX Application: 75213

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1998-12-24

75213 / 1

Active Ingredient

TRETINOIN

Application Number

75213

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1998-12-24

Regulatory Status

RX

1998
24 Dec
RX Application: 75264

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1998-12-24

75264 / 1

Active Ingredient

TRETINOIN

Application Number

75264

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1998-12-24

Regulatory Status

RX

1998
24 Dec
RX Application: 75265

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-12-24

75265 / 1

Active Ingredient

TRETINOIN

Application Number

75265

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-12-24

Regulatory Status

RX

2000
22 Feb
RX Application: 75529

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2000-02-22

75529 / 1

Active Ingredient

TRETINOIN

Application Number

75529

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2000-02-22

Regulatory Status

RX

2002
11 Jun
RX Application: 75589

Drug Name

TRETINOIN

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2002-06-11

75589 / 1

Active Ingredient

TRETINOIN

Application Number

75589

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2002-06-11

Regulatory Status

RX

1982
01 Jan
RX Application: 86413

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

86413 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

86413

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86413

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

86413 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

86413

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86413

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

86413 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

86413

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 87385

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

87385 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87385

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 87385

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

87385 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87385

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 87385

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

87385 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87385

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
15 Nov
Discontinued Application: 87285

Drug Name

TRIPLE SULFA

Product Number

1

Dosage Form

-

Strength

3.7%;2.86%;3.42%

Approval Date

1982-11-15

87285 / 1

Active Ingredient

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

Application Number

87285

Product Number

1

Dosage Form

-

Strength

3.7%;2.86%;3.42%

Approval Date

1982-11-15

Regulatory Status

Discontinued

2010
17 Nov
RX Application: 91573

Drug Name

TROSPIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2010-11-17

91573 / 1

Active Ingredient

TROSPIUM CHLORIDE

Application Number

91573

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2010-11-17

Regulatory Status

RX

2013
24 May
RX Application: 201291

Drug Name

TROSPIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2013-05-24

201291 / 1

Active Ingredient

TROSPIUM CHLORIDE

Application Number

201291

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2013-05-24

Regulatory Status

RX

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Drug Status Breakdown
104 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ALBUTEROL SULFATE

Application Number

203760

Product Number

1

Active Ingredient

ALBUTEROL SULFATE

Dosage Form

-

Strength

EQ 0.09MG BASE/INH

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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