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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
Sponsor:  InSite Vision
Therapeutic Category:  Antibiotic