Perrigo Company plc
FDA Approved Drugs

Perrigo Company plc

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.

OTC Discontinued Unclassified
  • Total Records 80
  • Latest Approval Date Mar 17, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
80
View
Unclassified
1
View
Discontinued
48
View
OTC
31
View
Company Overview

Company

Perrigo Company plc

Country

Ireland

Website

Visit Website

Email

enquiries@pharmacompass.com

Social Profiles

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Company Snapshot

Perrigo Company plc

The Sharp Building Hogan Place Dublin 2

Ireland

www.perrigo.com/ enquiries@pharmacompass.com View on Map
FDA Approved Drug Records ( 80 records )
1987
06 Apr
OTC Application: 70607

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1987-04-06

70607 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

70607

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1987-04-06

Regulatory Status

OTC

1986
01 Dec
OTC Application: 70608

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1986-12-01

70608 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

70608

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1986-12-01

Regulatory Status

OTC

2000
25 Feb
OTC Application: 75077

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2000-02-25

75077 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

75077

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2000-02-25

Regulatory Status

OTC

2001
26 Nov
OTC Application: 75794

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2001-11-26

75794 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Application Number

75794

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2001-11-26

Regulatory Status

OTC

1987
10 Apr
Discontinued Application: 71292

Drug Name

ANTITUSSIVE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1987-04-10

71292 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

71292

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1987-04-10

Regulatory Status

Discontinued

1990
31 Jan
Discontinued Application: 72526

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

72526 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

72526

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

Regulatory Status

Discontinued

1990
31 Jan
Discontinued Application: 72536

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

72536 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

72536

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1990-01-31

Regulatory Status

Discontinued

1997
26 Nov
Discontinued Application: 74579

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1997-11-26

74579 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

74579

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1997-11-26

Regulatory Status

Discontinued

1986
10 Jun
Discontinued Application: 70053

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1986-06-10

70053 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

70053

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1986-06-10

Regulatory Status

Discontinued

1987
23 Dec
Discontinued Application: 71478

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-12-23

71478 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

71478

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-12-23

Regulatory Status

Discontinued

-
Unclassified Application: 212137

Drug Name

BRINZOLAMIDE; BRIMONIDINE TARTRATE

Product Number

1

Dosage Form

-

Strength

0.2MG,10MG

Approval Date

-

212137 / 1

Active Ingredient

BRINZOLAMIDE;BRIMONIDINE TARTRATE

Application Number

212137

Product Number

1

Dosage Form

-

Strength

0.2MG,10MG

Approval Date

-

Regulatory Status

Unclassified

1987
08 Dec
Discontinued Application: 72097

Drug Name

CAP-PROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

72097 / 1

Active Ingredient

IBUPROFEN

Application Number

72097

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

2018
16 Nov
OTC Application: 210719

Drug Name

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2018-11-16

210719 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

210719

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2018-11-16

Regulatory Status

OTC

1998
22 Dec
OTC Application: 74937

Drug Name

CHILDRENS IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1998-12-22

74937 / 1

Active Ingredient

IBUPROFEN

Application Number

74937

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1998-12-22

Regulatory Status

OTC

1998
19 Jun
Discontinued Application: 74972

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

74972 / 1

Active Ingredient

CIMETIDINE

Application Number

74972

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

Regulatory Status

Discontinued

2001
12 Dec
Discontinued Application: 75427

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

5.2MG/SPRAY

Approval Date

2001-12-12

75427 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75427

Product Number

1

Dosage Form

-

Strength

5.2MG/SPRAY

Approval Date

2001-12-12

Regulatory Status

Discontinued

2011
22 Dec
Discontinued Application: 78361

Drug Name

DESLORATADINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-22

78361 / 1

Active Ingredient

DESLORATADINE

Application Number

78361

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-22

Regulatory Status

Discontinued

2019
16 May
OTC Application: 211253

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-05-16

211253 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

211253

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-05-16

Regulatory Status

OTC

1982
01 Jan
Discontinued Application: 83061

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83061 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

83061

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83061

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83061 / 2

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

83061

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83063

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

83063 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

83063

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
18 Sep
OTC Application: 40167

Drug Name

DOXYLAMINE SUCCINATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-09-18

40167 / 1

Active Ingredient

DOXYLAMINE SUCCINATE

Application Number

40167

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1996-09-18

Regulatory Status

OTC

2005
18 Mar
OTC Application: 75400

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-03-18

75400 / 1

Active Ingredient

FAMOTIDINE

Application Number

75400

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-03-18

Regulatory Status

OTC

2003
22 Aug
Discontinued Application: 75715

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-22

75715 / 1

Active Ingredient

FAMOTIDINE

Application Number

75715

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-22

Regulatory Status

Discontinued

1982
04 Mar
Discontinued Application: 86810

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-03-04

86810 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

86810

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-03-04

Regulatory Status

Discontinued

1982
04 Mar
Discontinued Application: 86811

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-03-04

86811 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

86811

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-03-04

Regulatory Status

Discontinued

1988
13 Jul
Discontinued Application: 71790

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1988-07-13

71790 / 1

Active Ingredient

FLUOCINONIDE

Application Number

71790

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1988-07-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84969

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

84969 / 3

Active Ingredient

HYDROCORTISONE

Application Number

84969

Product Number

3

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84970

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

84970 / 2

Active Ingredient

HYDROCORTISONE

Application Number

84970

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85026

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85026 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85026

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85028

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85028 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85028

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85662

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

85662 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85662

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85663

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85663 / 1

Active Ingredient

HYDROCORTISONE

Application Number

85663

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
08 Dec
OTC Application: 72096

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

72096 / 1

Active Ingredient

IBUPROFEN

Application Number

72096

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

Regulatory Status

OTC

1987
08 Dec
Discontinued Application: 72098

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

72098 / 1

Active Ingredient

IBUPROFEN

Application Number

72098

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

2002
14 Mar
Discontinued Application: 75995

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-03-14

75995 / 1

Active Ingredient

IBUPROFEN

Application Number

75995

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-03-14

Regulatory Status

Discontinued

2004
16 Jan
Discontinued Application: 76359

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-01-16

76359 / 1

Active Ingredient

IBUPROFEN

Application Number

76359

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-01-16

Regulatory Status

Discontinued

2004
16 Jan
OTC Application: 76359

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-01-16

76359 / 2

Active Ingredient

IBUPROFEN

Application Number

76359

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-01-16

Regulatory Status

OTC

2003
05 Nov
Discontinued Application: 76478

Drug Name

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML;15MG/5ML

Approval Date

2003-11-05

76478 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

76478

Product Number

1

Dosage Form

-

Strength

100MG/5ML;15MG/5ML

Approval Date

2003-11-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83060

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

83060 / 1

Active Ingredient

ISONIAZID

Application Number

83060

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
07 Feb
Discontinued Application: 75364

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2002-02-07

75364 / 1

Active Ingredient

KETOPROFEN

Application Number

75364

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2002-02-07

Regulatory Status

Discontinued

1992
21 Jan
Discontinued Application: 73243

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1992-01-21

73243 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73243

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1992-01-21

Regulatory Status

Discontinued

1992
30 Oct
Discontinued Application: 74194

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-10-30

74194 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

74194

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1992-10-30

Regulatory Status

Discontinued

2002
30 Aug
Discontinued Application: 76029

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2002-08-30

76029 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

76029

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2002-08-30

Regulatory Status

Discontinued

2004
24 Jun
Discontinued Application: 21512

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-06-24

21512 / 1

Active Ingredient

LORATADINE

Application Number

21512

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-06-24

Regulatory Status

Discontinued

2004
20 Aug
OTC Application: 75728

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

75728 / 1

Active Ingredient

LORATADINE

Application Number

75728

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

Regulatory Status

OTC

2003
29 Sep
OTC Application: 76011

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-09-29

76011 / 1

Active Ingredient

LORATADINE

Application Number

76011

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-09-29

Regulatory Status

OTC

2004
25 Jun
OTC Application: 76301

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-06-25

76301 / 1

Active Ingredient

LORATADINE

Application Number

76301

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-06-25

Regulatory Status

OTC

2004
04 Mar
OTC Application: 75989

Drug Name

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2004-03-04

75989 / 1

Active Ingredient

LORATADINE; PSEUDOEPHEDRINE SULFATE

Application Number

75989

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2004-03-04

Regulatory Status

OTC

2003
30 Jan
OTC Application: 76050

Drug Name

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2003-01-30

76050 / 1

Active Ingredient

LORATADINE; PSEUDOEPHEDRINE SULFATE

Application Number

76050

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2003-01-30

Regulatory Status

OTC

1982
01 Jan
Discontinued Application: 84546

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84546 / 1

Active Ingredient

MEPROBAMATE

Application Number

84546

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84547

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

84547 / 1

Active Ingredient

MEPROBAMATE

Application Number

84547

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
30 Mar
OTC Application: 76357

Drug Name

MICONAZOLE 3 COMBINATION PACK

Product Number

1

Dosage Form

-

Strength

2%,4%

Approval Date

2004-03-30

76357 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

76357

Product Number

1

Dosage Form

-

Strength

2%,4%

Approval Date

2004-03-30

Regulatory Status

OTC

1997
20 Mar
Discontinued Application: 74395

Drug Name

MICONAZOLE NITRATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1997-03-20

74395 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

74395

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1997-03-20

Regulatory Status

Discontinued

1997
15 May
OTC Application: 74760

Drug Name

MICONAZOLE NITRATE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-05-15

74760 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

74760

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-05-15

Regulatory Status

OTC

2011
28 Apr
OTC Application: 91344

Drug Name

MINOXIDIL

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-04-28

91344 / 1

Active Ingredient

MINOXIDIL

Application Number

91344

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-04-28

Regulatory Status

OTC

2001
13 Jun
OTC Application: 75598

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2001-06-13

75598 / 1

Active Ingredient

MINOXIDIL

Application Number

75598

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2001-06-13

Regulatory Status

OTC

2002
15 Mar
Discontinued Application: 75737

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2002-03-15

75737 / 1

Active Ingredient

MINOXIDIL

Application Number

75737

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2002-03-15

Regulatory Status

Discontinued

1997
13 Jan
OTC Application: 74661

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

1997-01-13

74661 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74661

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

1997-01-13

Regulatory Status

OTC

2004
17 Mar
OTC Application: 76518

Drug Name

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

220MG;120MG

Approval Date

2004-03-17

76518 / 1

Active Ingredient

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

76518

Product Number

1

Dosage Form

-

Strength

220MG;120MG

Approval Date

2004-03-17

Regulatory Status

OTC

2022
17 Mar
OTC Application: 215712

Drug Name

NASONEX 24HR ALLERGY

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2022-03-17

215712 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

215712

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2022-03-17

Regulatory Status

OTC

2009
10 Jul
OTC Application: 90711

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-07-10

90711 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

90711

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-07-10

Regulatory Status

OTC

2009
10 Jul
OTC Application: 90711

Drug Name

NICOTINE POLACRILEX

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-07-10

90711 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

90711

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-07-10

Regulatory Status

OTC

2012
09 Oct
OTC Application: 203690

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-10-09

203690 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

203690

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2012-10-09

Regulatory Status

OTC

2012
09 Oct
OTC Application: 203690

Drug Name

NICOTINE POLACRILEX

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-10-09

203690 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

203690

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-10-09

Regulatory Status

OTC

1982
01 Jan
Discontinued Application: 84968

Drug Name

NITROFURAZONE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

84968 / 1

Active Ingredient

NITROFURAZONE

Application Number

84968

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85130

Drug Name

NITROFURAZONE

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

85130 / 1

Active Ingredient

NITROFURAZONE

Application Number

85130

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
06 Jun
Discontinued Application: 62186

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-06-06

62186 / 2

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62186

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-06-06

Regulatory Status

Discontinued

1985
10 Oct
Discontinued Application: 62280

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-10

62280 / 2

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62280

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-10

Regulatory Status

Discontinued

2001
20 Dec
Discontinued Application: 76090

Drug Name

PERMETHRIN

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2001-12-20

76090 / 1

Active Ingredient

PERMETHRIN

Application Number

76090

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2001-12-20

Regulatory Status

Discontinued

2009
06 Oct
OTC Application: 90685

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2009-10-06

90685 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

90685

Product Number

1

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2009-10-06

Regulatory Status

OTC

2009
06 Oct
OTC Application: 90685

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

90685 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

90685

Product Number

2

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

Regulatory Status

OTC

1982
01 Jan
Discontinued Application: 85322

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

85322 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

85322

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
30 Aug
Discontinued Application: 76195

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2002-08-30

76195 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

76195

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2002-08-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84561

Drug Name

SECOBARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84561 / 1

Active Ingredient

SECOBARBITAL SODIUM

Application Number

84561

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84560

Drug Name

SODIUM PENTOBARBITAL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84560 / 1

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

84560

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
08 Dec
Discontinued Application: 72095

Drug Name

TAB-PROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

72095 / 1

Active Ingredient

IBUPROFEN

Application Number

72095

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1987-12-08

Regulatory Status

Discontinued

2001
21 Nov
OTC Application: 75915

Drug Name

TIOCONAZOLE

Product Number

1

Dosage Form

-

Strength

6.5%

Approval Date

2001-11-21

75915 / 1

Active Ingredient

TIOCONAZOLE

Application Number

75915

Product Number

1

Dosage Form

-

Strength

6.5%

Approval Date

2001-11-21

Regulatory Status

OTC

2009
30 Jul
Discontinued Application: 78104

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2009-07-30

78104 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

78104

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2009-07-30

Regulatory Status

Discontinued

2014
14 Nov
OTC Application: 78104

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2014-11-14

78104 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

78104

Product Number

2

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2014-11-14

Regulatory Status

OTC

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Drug Status Breakdown
80 total
  • OTC
  • Discontinued
  • Unclassified
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

ACETAMINOPHEN

Application Number

70607

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

120MG

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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