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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
06/12/2007
Trade Name:
Extina Foam, 2%
Generic Name or Proper Name (*):
ketoconazole
Indications Studied:
Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older
Label Changes Summary:
Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age Studies waived in children 0-12 years of age New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Stiefel Laboratories
NNPS:
FALSE'
Therapeutic Category:
Antifungal, topical
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