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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  07/31/2009
 
Trade Name:  Xerese
 
Generic or Proper Name (*):  acyclovir/ hydrocortisone
 
Indications Studied:  Recurrent herpes labialis (cold sores) in 12 years of age and older
 
Therapeutic Category:  Antiviral, topical
 
Ages Studied:  12 years and older
 
Study #:  1
 
Study Type:  Safety
 
Study Design:  Open Label
 
No Patients:  254
 
No Centers:  26
 
No Countries:  2
 
BPCA(B), PREA(P):  P
 
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