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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:
12/08/2000
Trade Name:
Protopic Ointment
Generic Name or Proper Name (*):
tacrolimus
Indications Studied:
Atopic dermatitis
Label Changes Summary:
Approved down to 2 years of age; lower dose of 0.03% twice daily recommended for patients 2-15 years of age
Product Labeling:
Labeling
Pediatric Rule (R):
R
Sponsor:
Fujisawa
NNPS:
FALSE'
Therapeutic Category:
Immunomodulator
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