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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 #:  4
Study Type:  Safety/Pharmacokinetic
Study Design:  Open label/Population Pharmacokinetic
No Patients:  81
No Centers:  5
No Countries:  1