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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  11/02/2010
 
Trade Name:  Ofirmev
 
Generic or Proper Name (*):  acetaminophen
 
Indications Studied:  Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever
 
Therapeutic Category:  Analgesic; Antipyretic
 
Ages Studied:  2 - 17 year olds
 
Study #:  2
 
Study Type:  Efficacy
 
Study Design:  Single-Blind/Active Control
 
No Patients:  67
 
No Centers:  11
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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