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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:
08/13/2004
Trade Name:
Ferrlecit
Generic Name or Proper Name (*):
sodium ferric gluconate complex
Indications Studied:
Iron deficiency anemia in chronic hemodialysis patients receiving supplemental erythropoietin therapy
Label Changes Summary:
Safety and effectiveness established in pediatric patients 6 -15 years old Patients <6 years of age not studied Information on dose, PK parameters and AE profile
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Watson
Pediatric Exclusivity Granted Date:
03/24/2004
NNPS:
FALSE'
Therapeutic Category:
Vitamin
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