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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:
10/16/2003
Trade Name:
Elestat Ophthalmic Solution
Generic Name or Proper Name (*):
epinastine
Indications Studied:
Prevention of itching associated with allergic conjunctivitis in children 3 years of age and older
Label Changes Summary:
Based on effectiveness and safety studies that included children down to 10 years of age Partial waiver for children < 3 years of age because the condition does not exist in the age group New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Allergan
NNPS:
FALSE'
Therapeutic Category:
Antihistamine, topical
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