LEO Pharma A/S

Overview

LEO Pharma A/S is a global healthcare company dedicated to helping people achieve healthy skin. As a leader in dermatology, LEO Pharma invests in R&D to improve treatment for skin conditions and is committed to advancing the care of patients worldwide.

Therapeutic areas

API / Drug Master Files

LEO Pharma A/S holds 2 active (7 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• CALCIPOTRIENE CREAMActive1993-10-08
• CALCIPOTRIENE HYDRATE DRUG SUBSTANCEActive1993-10-08
• HEPARINASE DRUG SUBSTANCEInactive1999-03-19
• HEPARIN SODIUM DRUG SUBSTANCEInactive1999-03-19
• CALCIPOTRIENE SCALP SOLUTIONInactive1994-03-30
• CALCIPOTRIENE OINTMENTInactive1989-11-27
• CALCIPOTRIENE DRUG SUBSTANCEInactive1989-11-01

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to LEO Pharma A/S in our records. PharmaTek screens the full directory against live FDA enforcement data.