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Details for New Drug Application (NDA): 021142

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NDA 021142 describes OLUX, which is a drug marketed by Delcor Asset Corp and Delcor Asset and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the OLUX profile page.

The generic ingredient in OLUX is clobetasol propionate. There are twelve 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: 021142

Pharmacology for NDA: 021142

Suppliers and Packaging for NDA: 021142

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clobetasol propionate
AEROSOL, FOAM;TOPICAL 021142 NDA Prestium Pharma, Inc. 40076-031 40076-031-00 100 g in 1 CAN (40076-031-00)
clobetasol propionate
AEROSOL, FOAM;TOPICAL 021142 NDA Prestium Pharma, Inc. 40076-031 40076-031-50 50 g in 1 CAN (40076-031-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:May 26, 2000TE:AB1RLD:Yes
Patent:6,126,920Patent Expiration:Mar 1, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021142

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Delcor Asset Corp
clobetasol propionate
AEROSOL, FOAM;TOPICAL021142-001May 26, 20006,126,920► subscribe
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