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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/22/2010
 
Trade Name:  Dulera Inhalation Aerosol
 
Generic or Proper Name (*):  mometasone furoate and formoterol fumarate
 
Indications Studied:  Asthma
 
Therapeutic Category:  Antiasthmatic
 
Ages Studied:  12 years and older
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  63
 
No Centers:  152
 
No Countries:  17
 
BPCA(B), PREA(P):  P
 
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