Details for New Drug Application (NDA): 207071

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NDA 207071 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 five 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 207071

Tradename:	FINACEA
Applicant:	Leo Pharma As
Ingredient:	azelaic acid
Patents:	5

Pharmacology for NDA: 207071

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 207071

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071	NDA	LEO Pharma Inc.	50222-303	50222-303-50	1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN
FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071	NDA	LEO Pharma Inc.	50222-303	50222-303-91	1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	15%
Approval Date:	Jul 29, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
Patent:	⤷ Sign Up	Patent Expiration:	Sep 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 1, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Expired US Patents for NDA 207071

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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