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Generated: May 26, 2017

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Details for New Drug Application (NDA): 020279

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NDA 020279 describes DERMATOP E EMOLLIENT, which is a drug marketed by Valeant Bermuda and is included in one NDA. It is available from three suppliers. Additional details are available on the DERMATOP E EMOLLIENT profile page.

The generic ingredient in DERMATOP E EMOLLIENT is prednicarbate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the prednicarbate profile page.

Summary for NDA: 020279

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020279

Suppliers and Packaging for NDA: 020279

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;TOPICAL 020279 NDA Valeant Pharmaceuticals North America LLC 0187-5182 0187-5182-60 60 g in 1 TUBE (0187-5182-60)
CREAM;TOPICAL 020279 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-880 66993-880-61 60 g in 1 TUBE (66993-880-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Oct 29, 1993TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020279

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda
CREAM;TOPICAL020279-001Oct 29, 19934,242,334► Subscribe
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