Last Updated: November 9, 2026

Details for New Drug Application (NDA): 021727

NDA 021727 describes AMLEXANOX, which is a drug marketed by Uluru and is included in one NDA. Additional details are available on the AMLEXANOX profile page.

The generic ingredient in AMLEXANOX is amlexanox. There is one drug master file entry for this compound. Additional details are available on the amlexanox profile page.

Summary for 021727

Tradename:	AMLEXANOX
Applicant:	Uluru
Ingredient:	amlexanox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	PATCH;TOPICAL			Strength	2MG
Approval Date:	Sep 29, 2004	TE:		RLD:	No

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