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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 Bayer Hlthcare and is included in one NDA. It is available from two 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 twenty-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

Summary for NDA: 021844

Tradename:
DESONATE
Applicant:
Bayer Hlthcare
Ingredient:
desonide
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:6,387,383Patent 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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