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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:  03/07/2014
 
Trade Name:  Pancreaze
 
Generic Name or Proper Name (*):  pancrelipase
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *New dosage strength of 2,600 USP lipase units to allow for dosing in infants up to 12 months*Postmarketing study* New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Pancreatic enzyme
 
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