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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:  10/06/2016
 
Trade Name:  Pertzye
 
Generic Name or Proper Name (*):  pancrelipase
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  * Labeling updated to include new dosage strength of 4,000 USP lipase units. * Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breastfeeding. Do not mix Pertzye capsule contents directly into formula or breast milk prior to administration. * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Digestive Care, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Pancreatic enzyme
 
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