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Generated: June 17, 2019

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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 three 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. One supplier is 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:3
Generic Entry Opportunity Date for 207589
Generic Entry Date for 207589*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, FOAM;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Patent:➤ Sign UpPatent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS
Patent:➤ Sign UpPatent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS

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