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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:  05/22/2000
 
Trade Name:  Optivar
 
Generic Name or Proper Name (*):  azelastine
 
Indications Studied:  Itching associated with Allergic Conjunctivitis
 
Label Changes Summary:  Safety and effectiveness established down to 3 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Muro Pharma/Asta Medica
 
Pediatric Exclusivity Granted Date:  08/11/1999
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine, topical
 
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