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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:  06/16/2000
 
Trade Name:  AmBisome Injection
 
Generic Name or Proper Name (*):  amphotericin B
 
Indications Studied:  Cryptococcal meningitis in HIV infected patients
 
Label Changes Summary:  * New indication approved down to 1 year of age; established a dose of 6mg/kg/day
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Fujisawa
 
NNPS:  FALSE
 
Therapeutic Category:  Infectious disease (non-viral)
 
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