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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204637

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NDA 204637 describes AZELAIC ACID, which is a drug marketed by Teva Pharms Usa, Actavis Labs Ut Inc, Encube, Glenmark Speclt, and Taro, and is included in five NDAs. It is available from five 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. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

Summary for 204637

Tradename:	AZELAIC ACID
Applicant:	Glenmark Speclt
Ingredient:	azelaic acid
Patents:	0

Pharmacology for NDA: 204637

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

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:	RX	Dosage:	GEL;TOPICAL			Strength	15%
Approval Date:	Nov 19, 2018	TE:	AB	RLD:	No

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