Leo Pharma
FDA Approved Drugs

Leo Pharma

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.

Unclassified RX Discontinued
  • Total Records 16
  • Latest Approval Date Jul 23, 2025
  • Data Source FDA
  • First Approval Date Dec 29, 1993
All
16
View
Unclassified
2
View
Discontinued
4
View
RX
10
View
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Company

Leo Pharma

Country

Denmark

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Leo Pharma

Industriparken 55

Denmark

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FDA Approved Drug Records ( 16 records )
-
Unclassified Application: 761180

Drug Name

ADBRY

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

761180 / 1

Active Ingredient

TRALOKINUMAB

Application Number

761180

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

Regulatory Status

Unclassified

2025
23 Jul
RX Application: 219155

Drug Name

ANZUPGO

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2025-07-23

219155 / 1

Active Ingredient

DELGOCITINIB

Application Number

219155

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2025-07-23

Regulatory Status

RX

2006
20 Oct
Discontinued Application: 21844

Drug Name

DESONATE

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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2006-10-20

21844 / 1

Active Ingredient

DESONIDE

Application Number

21844

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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2006-10-20

Regulatory Status

Discontinued

1993
29 Dec
RX Application: 20273

Drug Name

DOVONEX

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

1993-12-29

20273 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

20273

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

1993-12-29

Regulatory Status

RX

1996
22 Jul
RX Application: 20554

Drug Name

DOVONEX

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

1996-07-22

20554 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

20554

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

1996-07-22

Regulatory Status

RX

2015
16 Oct
RX Application: 207589

Drug Name

ENSTILAR

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2015-10-16

207589 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Application Number

207589

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2015-10-16

Regulatory Status

RX

2002
24 Dec
RX Application: 21470

Drug Name

FINACEA

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2002-12-24

21470 / 1

Active Ingredient

AZELAIC ACID

Application Number

21470

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2002-12-24

Regulatory Status

RX

2015
29 Jul
RX Application: 207071

Drug Name

FINACEA

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2015-07-29

207071 / 1

Active Ingredient

AZELAIC ACID

Application Number

207071

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2015-07-29

Regulatory Status

RX

2000
14 Jul
Discontinued Application: 20484

Drug Name

INNOHEP

Product Number

1

Dosage Form

-

Strength

20,000 IU/ML

Approval Date

2000-07-14

20484 / 1

Active Ingredient

TINZAPARIN SODIUM

Application Number

20484

Product Number

1

Dosage Form

-

Strength

20,000 IU/ML

Approval Date

2000-07-14

Regulatory Status

Discontinued

2012
23 Jan
Discontinued Application: 202833

Drug Name

PICATO

Product Number

1

Dosage Form

-

Strength

0.015%

Approval Date

2012-01-23

202833 / 1

Active Ingredient

INGENOL MEBUTATE

Application Number

202833

Product Number

1

Dosage Form

-

Strength

0.015%

Approval Date

2012-01-23

Regulatory Status

Discontinued

2012
23 Jan
Discontinued Application: 202833

Drug Name

PICATO

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

2012-01-23

202833 / 2

Active Ingredient

INGENOL MEBUTATE

Application Number

202833

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

2012-01-23

Regulatory Status

Discontinued

2000
08 Dec
RX Application: 50777

Drug Name

PROTOPIC

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2000-12-08

50777 / 1

Active Ingredient

TACROLIMUS

Application Number

50777

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2000-12-08

Regulatory Status

RX

2000
08 Dec
RX Application: 50777

Drug Name

PROTOPIC

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2000-12-08

50777 / 2

Active Ingredient

TACROLIMUS

Application Number

50777

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2000-12-08

Regulatory Status

RX

2006
09 Jan
RX Application: 21852

Drug Name

TACLONEX

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2006-01-09

21852 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Application Number

21852

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2006-01-09

Regulatory Status

RX

2008
09 May
RX Application: 22185

Drug Name

TACLONEX

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2008-05-09

22185 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Application Number

22185

Product Number

1

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

2008-05-09

Regulatory Status

RX

-
Unclassified Application: 22185

Drug Name

TACLONEX

Product Number

2

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

-

22185 / 2

Active Ingredient

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

Application Number

22185

Product Number

2

Dosage Form

-

Strength

0.064%;0.005%

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
16 total
  • Unclassified
  • 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

ADBRY

Application Number

761180

Product Number

1

Active Ingredient

TRALOKINUMAB

Dosage Form

-

Strength

150MG/ML

FDA Approved Drug Data

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