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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Aventis
 
Pediatric Exclusivity Granted Date:  07/12/1999
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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