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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:  11/27/2000
 
Trade Name:  Benzamycin Pak
 
Generic Name or Proper Name (*):  erythromycin-benzoyl peroxide
 
Indications Studied:  Acne vulgaris
 
Label Changes Summary:  Approved down to 12 years of age
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Dermik Laboratories, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiacne, topical
 
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