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. Seven 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

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	0.064%;0.005%
Approval Date:	Oct 16, 2015	TE:	AB	RLD:	Yes
Patent:	10,130,640*PED	Patent Expiration:	Dec 10, 2031	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	10,617,698	Patent Expiration:	Jun 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,660,908	Patent Expiration:	Jun 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

Expired US Patents for NDA 207589

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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	6,753,013	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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