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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020428

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NDA 020428 describes AZELEX, which is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. Additional details are available on the AZELEX profile page.

The generic ingredient in AZELEX 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 020428
Tradename:AZELEX
Applicant:Almirall
Ingredient:azelaic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020428
Suppliers and Packaging for NDA: 020428
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELEX azelaic acid CREAM;TOPICAL 020428 NDA Almirall, LLC 16110-869 16110-869-30 1 TUBE in 1 CARTON (16110-869-30) > 30 g in 1 TUBE
AZELEX azelaic acid CREAM;TOPICAL 020428 NDA Almirall, LLC 16110-869 16110-869-50 1 TUBE in 1 CARTON (16110-869-50) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength20%
Approval Date:Sep 13, 1995TE:RLD:Yes

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