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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:
02/08/2002
Trade Name:
Acular & Acular PF
Generic Name or Proper Name (*):
ketorolac
Indications Studied:
Relief of ocular itching due to seasonal allergic rhinitis and postoperative inflammation after cataract extraction
Label Changes Summary:
Safety and effectiveness established down to 3 years; previously approved down to 12 years
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Allergan
Pediatric Exclusivity Granted Date:
09/06/2001
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory
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