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Last Updated: November 21, 2024

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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 207589
Tradename:ENSTILAR
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene
Patents:8
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:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 10, 2031Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

Expired US Patents for NDA 207589

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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