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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:  10/24/2013
 
Trade Name:  Ecoza
 
Generic Name or Proper Name (*):  econazole nitrate
 
Indications Studied:  Treatment of interdigital tinea pedis
 
Label Changes Summary:  *Approved for use in 12 years and older * Safety findings for patients 12 - 17 years were similar to those in adults * Information on clinical trials and PK* New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AmDerma Pharmaceuticals, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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