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Generated: April 20, 2019

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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 Mylan Pharms Inc and is included in one NDA. It is available from three 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 fourteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 022013
Tradename:OLUX E
Applicant:Mylan Pharms Inc
Ingredient:clobetasol propionate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022013
Medical Subject Heading (MeSH) Categories for 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 AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8055 0378-8055-01 1 CAN in 1 CARTON (0378-8055-01) > 100 g in 1 CAN
OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013 NDA Mylan Pharmaceuticals Inc. 0378-8147 0378-8147-01 1 CAN in 1 CARTON (0378-8147-01) > 100 g in 1 CAN

Profile for product number 001

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

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