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Generated: November 15, 2018

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Details for New Drug Application (NDA): 021844

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NDA 021844 describes DESONATE, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DESONATE profile page.

The generic ingredient in DESONATE is desonide. There are thirty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 021844
Tradename:DESONATE
Applicant:Leo Pharma As
Ingredient:desonide
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021844
Medical Subject Heading (MeSH) Categories for 021844
Suppliers and Packaging for NDA: 021844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESONATE desonide GEL;TOPICAL 021844 NDA Intendis Inc. 10922-828 10922-828-06 1 TUBE in 1 CARTON (10922-828-06) > 60 g in 1 TUBE
DESONATE desonide GEL;TOPICAL 021844 NDA Intendis Inc. 10922-828 10922-828-12 2 TUBE in 1 CARTON (10922-828-12) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE AND OLDER

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