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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/31/2009
 
Trade Name:  Astepro Nasal Spray
 
Generic or Proper Name (*):  azelastine hydrochloride
 
Indications Studied:  Seasonal and perennial allergic rhinitis in patients 12 years of age and older.
 
Therapeutic Category:  Antihistamine
 
Ages Studied:  12 years and older
 
Study #:  4
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo
 
No Patients:  536
 
No Centers:  6
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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