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Cantor Fitzgerald
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020428

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NDA 020428 describes AZELEX, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 020428
Tradename:AZELEX
Applicant:Allergan
Ingredient:azelaic acid
Patents:0
Therapeutic Class:Dermatological Agents
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 N 0023-8694-30
AZELEX azelaic acid CREAM;TOPICAL 020428 NDA Allergan, Inc. 0023-8694 N 0023-8694-50

Profile for product number 001

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

Expired US Patents for NDA 020428

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan AZELEX azelaic acid CREAM;TOPICAL 020428-001 Sep 13, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Chinese Patent Office
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