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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:  07/18/2014
 
Trade Name:  Atropine Sulfate
 
Generic Name or Proper Name (*):  atropine sulfate
 
Indications Studied:  Mydriasis, cycloplegia, and penalization of the healthy eye in the treatment of amblyopia in children 3 months and older
 
Label Changes Summary:  *Approved for use in adults and pediatric patients 3 months and older. * Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, use in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. *New indication
 
PREA(P):  P
 
Sponsor:  Akorn
 
NNPS:  FALSE
 
Therapeutic Category:  Ophthalmologic
 
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