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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:  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  Opens a new window
Pediatric Rule (R):  R
Sponsor:  Fujisawa
Therapeutic Category:  Immunomodulator