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Last Updated: January 24, 2020

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Details for New Drug Application (NDA): 207589

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NDA 207589 describes ENSTILAR, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ENSTILAR profile page.

The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 207589
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene
Pharmacology for NDA: 207589
Suppliers and Packaging for NDA: 207589
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589 NDA LEO Pharma Inc. 50222-302 50222-302-60 1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN
ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589 NDA LEO Pharma Inc. 50222-302 50222-302-66 2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.064%;0.005%
Approval Date:Oct 16, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 30, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 30, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Dec 10, 2031Product Flag?Substance Flag?Delist Request?Y

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