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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Meda
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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