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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:
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
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
TRUE'
Therapeutic Category:
Antibiotic
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