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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Access Pharmaceuticals
NNPS:
TRUE'
Therapeutic Category:
Anti-inflammatory, topical
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