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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:  12/17/2004
 
Trade Name:  Augmentin ES-600 Powder for Oral Suspension
 
Generic Name or Proper Name (*):  amoxicillin; clavulanate
 
Indications Studied:  Treatment of acute bacterial sinusitis (ABS) (sinus infection) in children 3 months of age and older
 
Label Changes Summary:  No new pediatric studies Effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  TRUE'
 
Therapeutic Category:  Antibiotic
 
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