GALDERMA LABS LP
FDA Approved Drugs

GALDERMA LABS LP

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 OTC Unclassified
  • Total Records 30
  • Latest Approval Date May 22, 2026
  • Data Source FDA
  • First Approval Date Dec 14, 1984
All
30
View
Unclassified
5
View
Discontinued
9
View
OTC
2
View
RX
14
View
Company Overview

Company

GALDERMA LABS LP

Country

U.S.A

Website

Visit Website

Email

virginie.naigeon@galderma.com

Social Profiles

Company Snapshot

GALDERMA LABS LP

14501 N. Freeway Ft. Worth, TX 76177

U.S.A

www.galderma.com/us/ virginie.naigeon@galderma.com View on Map
FDA Approved Drug Records ( 30 records )
2019
04 Oct
RX Application: 211527

Drug Name

AKLIEF

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2019-10-04

211527 / 1

Active Ingredient

TRIFAROTENE

Application Number

211527

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2019-10-04

Regulatory Status

RX

1990
27 Aug
Discontinued Application: 20001

Drug Name

CAPEX

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1990-08-27

20001 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

20001

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1990-08-27

Regulatory Status

Discontinued

2003
24 Jul
RX Application: 21535

Drug Name

CLOBEX

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2003-07-24

21535 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

21535

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2003-07-24

Regulatory Status

RX

2005
27 Oct
RX Application: 21835

Drug Name

CLOBEX

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-10-27

21835 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

21835

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2005-10-27

Regulatory Status

RX

1984
14 Dec
RX Application: 19048

Drug Name

DESOWEN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1984-12-14

19048 / 1

Active Ingredient

DESONIDE

Application Number

19048

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1984-12-14

Regulatory Status

RX

1988
15 Jun
Discontinued Application: 71425

Drug Name

DESOWEN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1988-06-15

71425 / 1

Active Ingredient

DESONIDE

Application Number

71425

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1988-06-15

Regulatory Status

Discontinued

1992
24 Jan
Discontinued Application: 72354

Drug Name

DESOWEN

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1992-01-24

72354 / 1

Active Ingredient

DESONIDE

Application Number

72354

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1992-01-24

Regulatory Status

Discontinued

1996
31 May
Discontinued Application: 20338

Drug Name

DIFFERIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-05-31

20338 / 1

Active Ingredient

ADAPALENE

Application Number

20338

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-05-31

Regulatory Status

Discontinued

2016
08 Jul
OTC Application: 20380

Drug Name

DIFFERIN

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2016-07-08

20380 / 2

Active Ingredient

ADAPALENE

Application Number

20380

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2016-07-08

Regulatory Status

OTC

2000
26 May
RX Application: 20748

Drug Name

DIFFERIN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2000-05-26

20748 / 1

Active Ingredient

ADAPALENE

Application Number

20748

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2000-05-26

Regulatory Status

RX

2007
19 Jun
RX Application: 21753

Drug Name

DIFFERIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2007-06-19

21753 / 1

Active Ingredient

ADAPALENE

Application Number

21753

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2007-06-19

Regulatory Status

RX

2010
17 Mar
Discontinued Application: 22502

Drug Name

DIFFERIN

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-03-17

22502 / 1

Active Ingredient

ADAPALENE

Application Number

22502

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-03-17

Regulatory Status

Discontinued

2026
22 May
OTC Application: 220736

Drug Name

DIFFERIN EPIDUO

Product Number

1

Dosage Form

-

Strength

0.1%;2.5%

Approval Date

2026-05-22

220736 / 1

Active Ingredient

ADAPALENE; BENZOYL PEROXIDE

Application Number

220736

Product Number

1

Dosage Form

-

Strength

0.1%;2.5%

Approval Date

2026-05-22

Regulatory Status

OTC

-
Unclassified Application: 220736

Drug Name

DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)

Product Number

2

Dosage Form

-

Strength

15G

Approval Date

-

220736 / 2

Active Ingredient

ADAPALENE, BENZOYL PEROXIDE

Application Number

220736

Product Number

2

Dosage Form

-

Strength

15G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220736

Drug Name

DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)

Product Number

3

Dosage Form

-

Strength

30G

Approval Date

-

220736 / 3

Active Ingredient

ADAPALENE, BENZOYL PEROXIDE

Application Number

220736

Product Number

3

Dosage Form

-

Strength

30G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220736

Drug Name

DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)

Product Number

4

Dosage Form

-

Strength

45G

Approval Date

-

220736 / 4

Active Ingredient

ADAPALENE, BENZOYL PEROXIDE

Application Number

220736

Product Number

4

Dosage Form

-

Strength

45G

Approval Date

-

Regulatory Status

Unclassified

2008
08 Dec
Discontinued Application: 22320

Drug Name

EPIDUO

Product Number

1

Dosage Form

-

Strength

0.1%;2.5%

Approval Date

2008-12-08

22320 / 1

Active Ingredient

ADAPALENE; BENZOYL PEROXIDE

Application Number

22320

Product Number

1

Dosage Form

-

Strength

0.1%;2.5%

Approval Date

2008-12-08

Regulatory Status

Discontinued

1995
20 Sep
RX Application: 20531

Drug Name

METROCREAM

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1995-09-20

20531 / 1

Active Ingredient

METRONIDAZOLE

Application Number

20531

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1995-09-20

Regulatory Status

RX

1988
22 Nov
Discontinued Application: 19737

Drug Name

METROGEL

Product Number

1

Dosage Form

-

Strength

0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-11-22

19737 / 1

Active Ingredient

METRONIDAZOLE

Application Number

19737

Product Number

1

Dosage Form

-

Strength

0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-11-22

Regulatory Status

Discontinued

2005
30 Jun
RX Application: 21789

Drug Name

METROGEL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2005-06-30

21789 / 1

Active Ingredient

METRONIDAZOLE

Application Number

21789

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2005-06-30

Regulatory Status

RX

1998
24 Nov
RX Application: 20901

Drug Name

METROLOTION

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1998-11-24

20901 / 1

Active Ingredient

METRONIDAZOLE

Application Number

20901

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1998-11-24

Regulatory Status

RX

2004
27 Jul
Discontinued Application: 21415

Drug Name

METVIXIA

Product Number

1

Dosage Form

-

Strength

EQ 16.8% BASE

Approval Date

2004-07-27

21415 / 1

Active Ingredient

METHYL AMINOLEVULINATE HYDROCHLORIDE

Application Number

21415

Product Number

1

Dosage Form

-

Strength

EQ 16.8% BASE

Approval Date

2004-07-27

Regulatory Status

Discontinued

2013
23 Aug
RX Application: 204708

Drug Name

MIRVASO

Product Number

1

Dosage Form

-

Strength

EQ 0.33% BASE

Approval Date

2013-08-23

204708 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

204708

Product Number

1

Dosage Form

-

Strength

EQ 0.33% BASE

Approval Date

2013-08-23

Regulatory Status

RX

-
Unclassified Application: 761390

Drug Name

NEMLUVIO

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

-

761390 / 1

Active Ingredient

NEMOLIZUMAB-ILTO

Application Number

761390

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761391

Drug Name

NEMLUVIO

Product Number

1

Dosage Form

-

Strength

30mg

Approval Date

-

761391 / 1

Active Ingredient

NEMOLIZUMAB-ILTO

Application Number

761391

Product Number

1

Dosage Form

-

Strength

30mg

Approval Date

-

Regulatory Status

Unclassified

2006
26 May
RX Application: 50805

Drug Name

ORACEA

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2006-05-26

50805 / 1

Active Ingredient

DOXYCYCLINE

Application Number

50805

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2006-05-26

Regulatory Status

RX

2001
02 Feb
Discontinued Application: 50783

Drug Name

PERIOSTAT

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-02-02

50783 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50783

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2001-02-02

Regulatory Status

Discontinued

2014
19 Dec
RX Application: 206255

Drug Name

SOOLANTRA

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2014-12-19

206255 / 1

Active Ingredient

IVERMECTIN

Application Number

206255

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2014-12-19

Regulatory Status

RX

2002
18 Jan
RX Application: 21112

Drug Name

TRI-LUMA

Product Number

1

Dosage Form

-

Strength

0.01%;4%;0.05%

Approval Date

2002-01-18

21112 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Application Number

21112

Product Number

1

Dosage Form

-

Strength

0.01%;4%;0.05%

Approval Date

2002-01-18

Regulatory Status

RX

2009
23 Jan
RX Application: 22087

Drug Name

VECTICAL

Product Number

1

Dosage Form

-

Strength

3MCG/GM

Approval Date

2009-01-23

22087 / 1

Active Ingredient

CALCITRIOL

Application Number

22087

Product Number

1

Dosage Form

-

Strength

3MCG/GM

Approval Date

2009-01-23

Regulatory Status

RX

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Drug Status Breakdown
30 total
  • RX
  • Discontinued
  • OTC
  • 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

AKLIEF

Application Number

211527

Product Number

1

Active Ingredient

TRIFAROTENE

Dosage Form

-

Strength

0.005%

FDA Approved Drug Data

Approved drug product information

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