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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:
04/20/2000
Trade Name:
Lantus
Generic Name or Proper Name (*):
insulin glargine
Indications Studied:
Type 1 Diabetes
Label Changes Summary:
Safety and effectiveness established down to 6 years
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Aventis
Pediatric Exclusivity Granted Date:
07/12/1999
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
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