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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:  12/22/2004
 
Trade Name:  Pataday Ophthalmic Solution
 
Generic Name or Proper Name (*):  olopatadine
 
Indications Studied:  Treatment of ocular itching associated with allergic conjunctivitis (itchy eyes) in children 3 years of age and older
 
Label Changes Summary:  Based on clinical trials that included patients down to 3 years of age. New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine, topical
 
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