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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:  08/04/2005
 
Trade Name:  Loperamide Hydrochloride Soft Gelatin Capsules
 
Generic Name or Proper Name (*):  loperamide
 
Indications Studied:  Control symptoms of diarrhea in children 12 years of age and older
 
Label Changes Summary:  * New dosage form; new dosing regimen * No new clinical studies * Bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug * Studies waived in children 0-2 years of age
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Banner Pharmacaps
 
NNPS:  TRUE
 
Therapeutic Category:  Antidiarrheal
 
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