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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
 
PREA(P):  P
 
Sponsor:  Access Pharmaceuticals
 
NNPS:  TRUE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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