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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:
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 monthsPostmarketing studyNew dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Janssen
NNPS:
FALSE'
Therapeutic Category:
Pancreatic enzyme
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