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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 020273


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NDA 020273 describes DOVONEX, which is a drug marketed by Leo Pharma As and Leo Pharm and is included in three NDAs. It is available from one supplier. 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. Ten suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.
Summary for 020273
Tradename:DOVONEX
Applicant:Leo Pharma As
Ingredient:calcipotriene
Patents:0
Suppliers and Packaging for NDA: 020273
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOVONEX calcipotriene OINTMENT;TOPICAL 020273 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-878 66993-878-61 1 TUBE in 1 CARTON (66993-878-61) / 60 g in 1 TUBE
DOVONEX calcipotriene OINTMENT;TOPICAL 020273 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-878 66993-878-78 1 TUBE in 1 CARTON (66993-878-78) / 120 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 29, 1993TE:ABRLD:Yes

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