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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:  07/02/1999
 
Trade Name:  Zaditor Ophthalmic Soln.
 
Generic Name or Proper Name (*):  ketotifen fumarate
 
Indications Studied:  Allergic conjunctivitis
 
Label Changes Summary:  * Approved down to 3 years of age; efficacy extrapolated from adult data
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Novartis
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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