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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  09/29/2004
Trade Name:  Amlexanox Mucoadhesive Patch
Generic Name or Proper Name (*):  amlexanox
Indications Studied:  Treatment of apthous ulcers in children 12 years of age and older
Label Changes Summary:  * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth  12 years of age waived * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  Access Pharmaceuticals
Therapeutic Category:  Anti-inflammatory, topical