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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  05/01/2012
 
Trade Name:  Dymista
 
Generic or Proper Name (*):  azelastine hydrochloride and fluticasone proprionate
 
Indications Studied:  Relief of symptoms of seasonal allergic rhinitis
 
Therapeutic Category:  antihistamine; anti-inflammatory
 
Ages Studied:  12-17 years
 
Study #:  5
 
Study Type:  Efficacy/Safety/Tolerability
 
Study Design:  Open Label/Active Control/Parallel Group
 
No Patients:  50
 
No Centers:  37
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
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