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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 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. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the azelaic acid profile page.

Summary for NDA: 020428

azelaic acid
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
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
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020428

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
azelaic acid
CREAM;TOPICAL020428-001Sep 13, 19954,386,104<disabled>
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