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Generated: November 13, 2018

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Details for New Drug Application (NDA): 020428

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NDA 020428 describes AZELEX, which is a drug marketed by Aqua Pharms Llc 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. Six suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 020428
Tradename:AZELEX
Applicant:Aqua Pharms Llc
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 Allergan, Inc. 0023-8694 0023-8694-30 1 TUBE in 1 CARTON (0023-8694-30) > 30 g in 1 TUBE
AZELEX azelaic acid CREAM;TOPICAL 020428 NDA Allergan, Inc. 0023-8694 0023-8694-50 1 TUBE in 1 CARTON (0023-8694-50) > 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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