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Generated: November 15, 2018

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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 one NDA. It is available from five suppliers. There are seven patents protecting this drug. 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 207071
Tradename:FINACEA
Applicant:Leo Pharma As
Ingredient:azelaic acid
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 207071
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:RXDosage:AEROSOL, FOAM;TOPICALStrength15%
Approval Date:Jul 29, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 29, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 18, 2027Product Flag?YSubstance Flag?Delist Request?

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