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FDA NDA · NDA021727

AMLEXANOX

Sponsor: ULURU

APPLICATION
NDA021727
TYPE
NDA
ORIGINAL APPROVAL
2004-09-29
LATEST ACTION
2008-11-06
ROUTE
TOPICAL
DOSAGE FORM
PATCH
MARKETING STATUS
Discontinued

Products

AMLEXANOXDiscontinued
AMLEXANOX 2MG · PATCH · TOPICAL

Approval history

2008-11-06Manufacturing (CMC) · Supplement 2AP
2004-09-29Type 3 - New Dosage Form · Original · standardReviewAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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