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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:
06/08/2007
Trade Name:
Timolol GFS
Generic Name or Proper Name (*):
timolol
Indications Studied:
Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension
Label Changes Summary:
Extended indication from adults to pediatric patients The adverse reaction profile was comparable to that seen in adults
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Falcon Pharmaceuticals
Pediatric Exclusivity Granted Date:
02/28/2007
NNPS:
FALSE'
Therapeutic Category:
Ophthalmologic hypotensive
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