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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:  12/15/2000
 
Trade Name:  Glucophage (immediate release)
 
Generic Name or Proper Name (*):  metformin
 
Indications Studied:  Diabetes Mellitus
 
Label Changes Summary:  * Safety and effectiveness as monotherapy established in patients 10-16 years of age
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  03/15/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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