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Last Updated: December 19, 2025

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 three suppliers. There are four 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. Nine 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:	0

Pharmacology for NDA: 021470

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

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	LEO Pharma, Inc	50222-505	50222-505-50	1 TUBE in 1 CARTON (50222-505-50) / 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	15%
Approval Date:	Dec 24, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021470

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	4,713,394	⤷ Get Started Free
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	6,534,070	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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