Details for New Drug Application (NDA): 020428

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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. Eight 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

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

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:	RX	Dosage:	CREAM;TOPICAL			Strength	20%
Approval Date:	Sep 13, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020428

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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