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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
Sponsor:  Muro Pharma/Asta Medica
Pediatric Exclusivity Granted Date:  08/11/1999
Therapeutic Category:  Antihistamine, topical