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Generated: November 20, 2018

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Details for New Drug Application (NDA): 021470

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NDA 021470 describes FINACEA, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from five suppliers. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FINACEA profile page.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 021470
Tradename:FINACEA
Applicant:Leo Pharma As
Ingredient:azelaic acid
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021470
Suppliers and Packaging for NDA: 021470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINACEA azelaic acid GEL;TOPICAL 021470 NDA AUTHORIZED GENERIC Sandoz Inc 0781-7172 0781-7172-50 1 TUBE in 1 CARTON (0781-7172-50) > 50 g in 1 TUBE
FINACEA azelaic acid GEL;TOPICAL 021470 NDA Intendis Inc. 10922-825 10922-825-02 1 TUBE in 1 CARTON (10922-825-02) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength15%
Approval Date:Dec 24, 2002TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 18, 2018Product Flag?Substance Flag?Delist Request?

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