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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:  04/27/2007
 
Trade Name:  Azasite Ophthalmic Solution 1%
 
Generic Name or Proper Name (*):  azithromycin
 
Indications Studied:  Treatment of bacterial conjunctivitis caused by certain microorganisms in patients down to 1 year of age
 
Label Changes Summary:  Effectiveness and safety were established in controlled clinical trials including patients down to 1 years of age Dosing information provided New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  InSite Vision
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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