Fougera Pharmaceuticals Inc. RX
FDA Approved Drugs

Fougera Pharmaceuticals Inc. RX

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
  • Total Records 87
  • Latest Approval Date May 11, 2016
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
120
View
Discontinued
33
View
RX
87
View
Company Overview

Company

Fougera Pharmaceuticals Inc. RX

Country

U.S.A

Website

Email

Social Profiles

Company Snapshot

Fougera Pharmaceuticals Inc. RX

U.S.A

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FDA Approved Drug Records ( 87 records )
2016
11 May
RX Application: 206633

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2016-05-11

206633 / 1

Active Ingredient

ACYCLOVIR

Application Number

206633

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2016-05-11

Regulatory Status

RX

2010
30 Jun
RX Application: 90824

Drug Name

ADAPALENE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-06-30

90824 / 1

Active Ingredient

ADAPALENE

Application Number

90824

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-06-30

Regulatory Status

RX

2005
18 Jul
RX Application: 76884

Drug Name

ALCLOMETASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-07-18

76884 / 1

Active Ingredient

ALCLOMETASONE DIPROPIONATE

Application Number

76884

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-07-18

Regulatory Status

RX

2005
12 Jul
RX Application: 76973

Drug Name

ALCLOMETASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-07-12

76973 / 1

Active Ingredient

ALCLOMETASONE DIPROPIONATE

Application Number

76973

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-07-12

Regulatory Status

RX

1984
26 Jun
RX Application: 19137

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1984-06-26

19137 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

19137

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1984-06-26

Regulatory Status

RX

1984
04 Sep
RX Application: 19141

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1984-09-04

19141 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

19141

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1984-09-04

Regulatory Status

RX

1985
12 Aug
RX Application: 70275

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1985-08-12

70275 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

70275

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1985-08-12

Regulatory Status

RX

2003
13 May
RX Application: 75276

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2003-05-13

75276 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

75276

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2003-05-13

Regulatory Status

RX

1999
22 Jun
RX Application: 75373

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1999-06-22

75373 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

75373

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1999-06-22

Regulatory Status

RX

2003
09 Dec
RX Application: 76215

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2003-12-09

76215 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

76215

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2003-12-09

Regulatory Status

RX

2007
21 May
RX Application: 77111

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2007-05-21

77111 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

77111

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2007-05-21

Regulatory Status

RX

1983
31 Aug
RX Application: 18861

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

18861 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

18861

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

Regulatory Status

RX

1983
31 Aug
RX Application: 18865

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

18865 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

18865

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

Regulatory Status

RX

1983
31 Aug
RX Application: 18866

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

18866 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

18866

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-08-31

Regulatory Status

RX

2008
06 May
RX Application: 78305

Drug Name

CALCIPOTRIENE

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2008-05-06

78305 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

78305

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2008-05-06

Regulatory Status

RX

2004
06 Aug
RX Application: 76422

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2004-08-06

76422 / 1

Active Ingredient

CICLOPIROX

Application Number

76422

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2004-08-06

Regulatory Status

RX

2004
29 Dec
RX Application: 76435

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2004-12-29

76435 / 1

Active Ingredient

CICLOPIROX

Application Number

76435

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2004-12-29

Regulatory Status

RX

2008
10 Jun
RX Application: 77896

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2008-06-10

77896 / 1

Active Ingredient

CICLOPIROX

Application Number

77896

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2008-06-10

Regulatory Status

RX

2010
25 May
RX Application: 90146

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-05-25

90146 / 1

Active Ingredient

CICLOPIROX

Application Number

90146

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-05-25

Regulatory Status

RX

1997
05 Jun
RX Application: 64159

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1997-06-05

64159 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

64159

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1997-06-05

Regulatory Status

RX

2000
28 Jan
RX Application: 64160

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2000-01-28

64160 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

64160

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2000-01-28

Regulatory Status

RX

2002
31 Jan
RX Application: 65067

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2002-01-31

65067 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

65067

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2002-01-31

Regulatory Status

RX

2004
27 Dec
RX Application: 65139

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2004-12-27

65139 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

65139

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2004-12-27

Regulatory Status

RX

1996
30 Sep
RX Application: 74392

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1996-09-30

74392 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74392

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1996-09-30

Regulatory Status

RX

1996
23 Feb
RX Application: 74407

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1996-02-23

74407 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74407

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1996-02-23

Regulatory Status

RX

2000
15 Feb
RX Application: 75368

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2000-02-15

75368 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75368

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2000-02-15

Regulatory Status

RX

1999
08 Feb
RX Application: 75391

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-02-08

75391 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75391

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-02-08

Regulatory Status

RX

1999
26 May
RX Application: 75430

Drug Name

CLOBETASOL PROPIONATE (EMOLLIENT)

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-05-26

75430 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75430

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1999-05-26

Regulatory Status

RX

2008
02 Sep
RX Application: 78338

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2008-09-02

78338 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

78338

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2008-09-02

Regulatory Status

RX

2001
05 Jun
RX Application: 75502

Drug Name

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2001-06-05

75502 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Application Number

75502

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2001-06-05

Regulatory Status

RX

2005
16 Jun
RX Application: 76516

Drug Name

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2005-06-16

76516 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Application Number

76516

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2005-06-16

Regulatory Status

RX

2001
12 Mar
RX Application: 75751

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2001-03-12

75751 / 1

Active Ingredient

DESONIDE

Application Number

75751

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2001-03-12

Regulatory Status

RX

2002
19 Mar
RX Application: 75860

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-03-19

75860 / 1

Active Ingredient

DESONIDE

Application Number

75860

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-03-19

Regulatory Status

RX

2010
29 Jun
RX Application: 78369

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2010-06-29

78369 / 1

Active Ingredient

DESOXIMETASONE

Application Number

78369

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2010-06-29

Regulatory Status

RX

2012
28 Sep
RX Application: 78657

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2012-09-28

78657 / 1

Active Ingredient

DESOXIMETASONE

Application Number

78657

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2012-09-28

Regulatory Status

RX

1997
30 Sep
RX Application: 64184

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-09-30

64184 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

64184

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-09-30

Regulatory Status

RX

1982
16 Dec
RX Application: 88167

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-12-16

88167 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88167

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-12-16

Regulatory Status

RX

1982
16 Dec
RX Application: 88168

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-12-16

88168 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88168

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-12-16

Regulatory Status

RX

1982
16 Dec
RX Application: 88169

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-12-16

88169 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88169

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-12-16

Regulatory Status

RX

1982
16 Dec
RX Application: 88170

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-12-16

88170 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88170

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-12-16

Regulatory Status

RX

1994
30 Dec
RX Application: 72933

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-12-30

72933 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72933

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-12-30

Regulatory Status

RX

1995
27 Feb
RX Application: 72934

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-02-27

72934 / 1

Active Ingredient

FLUOCINONIDE

Application Number

72934

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-02-27

Regulatory Status

RX

1994
17 Oct
RX Application: 73030

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-10-17

73030 / 1

Active Ingredient

FLUOCINONIDE

Application Number

73030

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1994-10-17

Regulatory Status

RX

1997
26 Aug
RX Application: 74905

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-08-26

74905 / 1

Active Ingredient

FLUOCINONIDE

Application Number

74905

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-08-26

Regulatory Status

RX

2014
14 Jul
RX Application: 200735

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2014-07-14

200735 / 1

Active Ingredient

FLUOCINONIDE

Application Number

200735

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2014-07-14

Regulatory Status

RX

2004
23 Jun
RX Application: 76586

Drug Name

FLUOCINONIDE EMULSIFIED BASE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-06-23

76586 / 1

Active Ingredient

FLUOCINONIDE

Application Number

76586

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-06-23

Regulatory Status

RX

2004
14 May
RX Application: 76451

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-05-14

76451 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

76451

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-05-14

Regulatory Status

RX

1984
05 Oct
RX Application: 62533

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1984-10-05

62533 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62533

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1984-10-05

Regulatory Status

RX

2004
16 Dec
RX Application: 77001

Drug Name

HALOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-12-16

77001 / 1

Active Ingredient

HALOBETASOL PROPIONATE

Application Number

77001

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2004-12-16

Regulatory Status

RX

1982
01 Jan
RX Application: 80692

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80692 / 1

Active Ingredient

HYDROCORTISONE

Application Number

80692

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 80693

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80693 / 3

Active Ingredient

HYDROCORTISONE

Application Number

80693

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1993
28 May
RX Application: 81203

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1993-05-28

81203 / 1

Active Ingredient

HYDROCORTISONE

Application Number

81203

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1993-05-28

Regulatory Status

RX

1986
16 Dec
RX Application: 89414

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1986-12-16

89414 / 1

Active Ingredient

HYDROCORTISONE

Application Number

89414

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1986-12-16

Regulatory Status

RX

2010
25 Feb
RX Application: 78548

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2010-02-25

78548 / 1

Active Ingredient

IMIQUIMOD

Application Number

78548

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2010-02-25

Regulatory Status

RX

2004
28 Apr
RX Application: 76294

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2004-04-28

76294 / 1

Active Ingredient

KETOCONAZOLE

Application Number

76294

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2004-04-28

Regulatory Status

RX

1982
01 Jan
RX Application: 80198

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

80198 / 1

Active Ingredient

LIDOCAINE

Application Number

80198

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

Regulatory Status

RX

2003
18 Aug
RX Application: 76453

Drug Name

LIDOCAINE AND PRILOCAINE

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-08-18

76453 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

76453

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-08-18

Regulatory Status

RX

2004
28 May
RX Application: 76408

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2004-05-28

76408 / 1

Active Ingredient

METRONIDAZOLE

Application Number

76408

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2004-05-28

Regulatory Status

RX

2006
06 Jun
RX Application: 77018

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-06-06

77018 / 1

Active Ingredient

METRONIDAZOLE

Application Number

77018

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-06-06

Regulatory Status

RX

2006
24 May
RX Application: 77197

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-05-24

77197 / 1

Active Ingredient

METRONIDAZOLE

Application Number

77197

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

2006-05-24

Regulatory Status

RX

2007
29 Nov
RX Application: 75919

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-11-29

75919 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

75919

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-11-29

Regulatory Status

RX

2005
28 Mar
RX Application: 77061

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2005-03-28

77061 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

77061

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2005-03-28

Regulatory Status

RX

2005
30 Nov
RX Application: 65192

Drug Name

MUPIROCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2005-11-30

65192 / 1

Active Ingredient

MUPIROCIN

Application Number

65192

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2005-11-30

Regulatory Status

RX

1988
08 Jul
RX Application: 87355

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1988-07-08

87355 / 1

Active Ingredient

NITROGLYCERIN

Application Number

87355

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1988-07-08

Regulatory Status

RX

1982
23 Sep
RX Application: 62124

Drug Name

NYSTATIN

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-09-23

62124 / 2

Active Ingredient

NYSTATIN

Application Number

62124

Product Number

2

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-09-23

Regulatory Status

RX

1982
01 Jan
RX Application: 62129

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-01-01

62129 / 1

Active Ingredient

NYSTATIN

Application Number

62129

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

1982-01-01

Regulatory Status

RX

1984
07 Jun
RX Application: 62517

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1984-06-07

62517 / 1

Active Ingredient

NYSTATIN

Application Number

62517

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1984-06-07

Regulatory Status

RX

1985
08 Oct
RX Application: 62599

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-08

62599 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62599

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-08

Regulatory Status

RX

1985
09 Oct
RX Application: 62602

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-09

62602 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62602

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1985-10-09

Regulatory Status

RX

1988
30 Dec
RX Application: 19828

Drug Name

OXISTAT

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1988-12-30

19828 / 1

Active Ingredient

OXICONAZOLE NITRATE

Application Number

19828

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

1988-12-30

Regulatory Status

RX

2007
09 Mar
RX Application: 77236

Drug Name

PREDNICARBATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-03-09

77236 / 1

Active Ingredient

PREDNICARBATE

Application Number

77236

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-03-09

Regulatory Status

RX

2006
17 Nov
RX Application: 77015

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2006-11-17

77015 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

77015

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2006-11-17

Regulatory Status

RX

2014
09 Sep
RX Application: 200744

Drug Name

TACROLIMUS

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-09-09

200744 / 1

Active Ingredient

TACROLIMUS

Application Number

200744

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-09-09

Regulatory Status

RX

2014
09 Sep
RX Application: 200744

Drug Name

TACROLIMUS

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2014-09-09

200744 / 2

Active Ingredient

TACROLIMUS

Application Number

200744

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2014-09-09

Regulatory Status

RX

2004
01 Oct
RX Application: 21735

Drug Name

TERCONAZOLE

Product Number

1

Dosage Form

-

Strength

0.8%

Approval Date

2004-10-01

21735 / 1

Active Ingredient

TERCONAZOLE

Application Number

21735

Product Number

1

Dosage Form

-

Strength

0.8%

Approval Date

2004-10-01

Regulatory Status

RX

2005
18 Feb
RX Application: 76712

Drug Name

TERCONAZOLE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2005-02-18

76712 / 1

Active Ingredient

TERCONAZOLE

Application Number

76712

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2005-02-18

Regulatory Status

RX

2003
21 Apr
RX Application: 40467

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2003-04-21

40467 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40467

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2003-04-21

Regulatory Status

RX

2003
21 Apr
RX Application: 40467

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2003-04-21

40467 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

40467

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2003-04-21

Regulatory Status

RX

1982
01 Jan
RX Application: 85691

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

85691 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85691

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85691

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

85691 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85691

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85691

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

85691 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85691

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85692

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

85692 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85692

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85692

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

85692 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85692

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 85692

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

85692 / 3

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

85692

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86576

Drug Name

TYZINE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

86576 / 1

Active Ingredient

TETRAHYDROZOLINE HYDROCHLORIDE

Application Number

86576

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86576

Drug Name

TYZINE

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

86576 / 2

Active Ingredient

TETRAHYDROZOLINE HYDROCHLORIDE

Application Number

86576

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 86576

Drug Name

TYZINE

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

86576 / 3

Active Ingredient

TETRAHYDROZOLINE HYDROCHLORIDE

Application Number

86576

Product Number

3

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

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Drug Status Breakdown
87 total
  • RX
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

ACYCLOVIR

Application Number

206633

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

5%

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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