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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072354

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NDA 072354 describes DESOWEN, which is a drug marketed by Galderma Labs Lp and is included in three NDAs. It is available from five suppliers. Additional details are available on the DESOWEN profile page.

The generic ingredient in DESOWEN is desonide. There are twenty-nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

Summary for NDA: 072354

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

Pharmacology for NDA: 072354

Suppliers and Packaging for NDA: 072354

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOWEN
desonide
LOTION;TOPICAL 072354 ANDA Galderma Laboratories, L.P. 0299-5765 0299-5765-02 59 g in 1 BOTTLE (0299-5765-02)
DESOWEN
desonide
LOTION;TOPICAL 072354 ANDA Galderma Laboratories, L.P. 0299-5765 0299-5765-04 1 BOTTLE in 1 CARTON (0299-5765-04) > 118 g in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Jan 24, 1992TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chubb
Argus Health
QuintilesIMS
Covington
Dow
AstraZeneca
US Army
Farmers Insurance
Johnson and Johnson
Fish and Richardson

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