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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 019048

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NDA 019048 describes DESOWEN, which is a drug marketed by Galderma Labs Lp and is included in three NDAs. It is available from three suppliers. Additional details are available on the DESOWEN profile page.

The generic ingredient in DESOWEN is desonide. There are thirty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 019048
Applicant:Galderma Labs Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 019048
Medical Subject Heading (MeSH) Categories for 019048
Suppliers and Packaging for NDA: 019048
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOWEN desonide CREAM;TOPICAL 019048 NDA Galderma Laboratories, L.P. 0299-5770 0299-5770-15 1 TUBE in 1 CARTON (0299-5770-15) > 15 g in 1 TUBE
DESOWEN desonide CREAM;TOPICAL 019048 NDA Galderma Laboratories, L.P. 0299-5770 0299-5770-60 1 TUBE in 1 CARTON (0299-5770-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Dec 14, 1984TE:ABRLD:No

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