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Details for New Drug Application (NDA): 022013

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NDA 022013 describes OLUX E, which is a drug marketed by Delcor Asset and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the OLUX E profile page.

The generic ingredient in OLUX E is clobetasol propionate. There are thirteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 022013

Tradename:
OLUX E
Applicant:
Delcor Asset
Ingredient:
clobetasol propionate
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022013

Suppliers and Packaging for NDA: 022013

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLUX E
clobetasol propionate
AEROSOL, FOAM;TOPICAL 022013 NDA Prestium Pharma, Inc. 40076-101 40076-101-00 100 g in 1 CAN (40076-101-00)
OLUX E
clobetasol propionate
AEROSOL, FOAM;TOPICAL 022013 NDA Prestium Pharma, Inc. 40076-101 40076-101-50 50 g in 1 CAN (40076-101-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:Jan 12, 2007TE:AB2RLD:Yes
Patent:6,730,288Patent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,029,659Patent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,460,641Patent Expiration:Nov 5, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES


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