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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Baxter
Federal Trade Commission
Accenture
Johnson and Johnson
Covington
Merck
UBS
Farmers Insurance

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207071

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NDA 207071 describes FINACEA , which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 207071
Tradename:FINACEA
Applicant:Bayer Hlthcare
Ingredient:azelaic acid
Patents:7
Therapeutic Class:Dermatological Agents
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 Bayer HealthCare Pharmaceuticals Inc. 50419-829 N 50419-829-71
FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-829 N 50419-829-01

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:➤ Sign UpPatent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Sep 18, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Teva
Chubb
Merck
Moodys
Express Scripts
QuintilesIMS
Chinese Patent Office
Fuji

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