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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:  04/14/2004
 
Trade Name:  Trusopt
 
Generic Name or Proper Name (*):  dorzolamide
 
Indications Studied:  Reduction in intraocular pressure
 
Label Changes Summary:  * Safety and IOP-lowering effects have been demonstrated in pediatric patients * Adverse event profile was comparable to that seen in adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  01/05/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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