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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  08/31/2009
 
Trade Name:  Astepro Nasal Spray
 
Generic Name or Proper Name (*):  azelastine hydrochloride
 
Indications Studied:  Seasonal and perennial allergic rhinitis in patients 12 years of age and older.
 
Label Changes Summary:  * Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older * Information on clinical trials, dosing, and adverse events (AEs) * New indication (PAR) and dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Meda
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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