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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Allergan
 
Pediatric Exclusivity Granted Date:  09/06/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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