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Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021470

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NDA 021470 describes FINACEA, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 021470
Applicant:Bayer Hlthcare
Ingredient:azelaic acid
Therapeutic Class:Dermatological Agents
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 Intendis Inc. 10922-825 E 10922-825-02
FINACEA azelaic acid GEL;TOPICAL 021470 NDA Intendis Inc. 10922-826 E 10922-826-10

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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