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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:  06/15/2011
 
Trade Name:  Zenpep
 
Generic Name or Proper Name (*):  pancrelipase
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  * New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eurand
 
NNPS:  TRUE
 
Therapeutic Category:  Pancreatic enzyme
 
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