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Last Updated: November 19, 2019

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Details for New Drug Application (NDA): 020554

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NDA 020554 describes DOVONEX, which is a drug marketed by Leo Pharma As and Leo Pharm and is included in three NDAs. It is available from three suppliers. Additional details are available on the DOVONEX profile page.

The generic ingredient in DOVONEX is calcipotriene. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.
Summary for 020554
Tradename:DOVONEX
Applicant:Leo Pharma As
Ingredient:calcipotriene
Patents:0
Pharmacology for NDA: 020554
Suppliers and Packaging for NDA: 020554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOVONEX calcipotriene CREAM;TOPICAL 020554 NDA LEO Pharma Inc. 50222-260 50222-260-06 100 CARTON in 1 CASE (50222-260-06) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE
DOVONEX calcipotriene CREAM;TOPICAL 020554 NDA LEO Pharma Inc. 50222-260 50222-260-12 50 CARTON in 1 CASE (50222-260-12) > 1 TUBE in 1 CARTON > 120 g in 1 TUBE
Paragraph IV (Patent) Challenges for 020554
Tradename Dosage Ingredient NDA Submissiondate
DOVONEX CREAM;TOPICAL calcipotriene 020554 2009-12-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.005%
Approval Date:Jul 22, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020554

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996   Start Trial   Start Trial
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996   Start Trial   Start Trial
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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