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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/27/2010
 
Trade Name:  Augmentin XR
 
Generic or Proper Name (*):  amoxicillin/clavulanate potassium
 
Indications Studied:  Community-acquired pneumonia or acute bacterial sinusitis
 
Therapeutic Category:  Antibiotic
 
Ages Studied:  Adolescents <= 16 years old
 
Study #:  1
 
Study Type:  Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  44
 
No Centers:  6
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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