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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:  10/19/2006
 
Trade Name:  Zaditor ophthalmic solution
 
Generic Name or Proper Name (*):  ketotifen
 
Indications Studied:  Temporary relief of itchy eyes in children 3 years of age and older OTC
 
Label Changes Summary:  * No new studies submitted * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novartis
 
NNPS:  TRUE
 
Therapeutic Category:  Antihistamine, topical
 
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