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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 204637

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NDA 204637 describes AZELAIC ACID, which is a drug marketed by Actavis Labs Ut Inc, Glenmark Pharms, Taro, and Tolmar, and is included in four NDAs. It is available from four suppliers. Additional details are available on the AZELAIC ACID profile page.

The generic ingredient in AZELAIC ACID is azelaic acid. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 204637
Applicant:Glenmark Pharms
Ingredient:azelaic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 204637
Suppliers and Packaging for NDA: 204637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELAIC ACID azelaic acid GEL;TOPICAL 204637 ANDA Glenmark Pharmaceuticals Inc., USA 68462-626 68462-626-52 1 TUBE in 1 CARTON (68462-626-52) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength15%
Approval Date:Nov 19, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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