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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 two 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 NDA: 207589

Tradename:
ENSTILAR
Applicant:
Leo Pharma As
Ingredient:
betamethasone dipropionate; calcipotriene
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 207589

Ingredient-typeVitamin D
Mechanism of ActionCorticosteroid 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

Summary 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:Oct 16, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:6,753,013Patent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS
Patent:9,119,781Patent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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