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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:
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
Pediatric Rule (R):
R
Sponsor:
Fujisawa
NNPS:
FALSE'
Therapeutic Category:
Infectious disease (non-viral)
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