You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020428


✉ Email this page to a colleague

« Back to Dashboard


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
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

Expired US Patents for NDA 020428

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.