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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:
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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