;
POLYETHYLENE GLYCOL
TALC
HYPROMELLOSES
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (Very dark yellow to brownish orange) Score 2pieces
Shape ROUND (biconvex with bevelled edges) Size 9mm
Flavor Imprint Code NVR;SA
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0078-0401-34 90TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021588 05/15/2001
GLEEVEC
imatinib mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0438
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE(IMATINIB) IMATINIB MESYLATE 400mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
FERRIC OXIDE YELLOW
HYPROMELLOSES
Product Characteristics
Color YELLOW (Very dark yellow to brownish orange) Score 2pieces
Shape OVAL (biconvex with bevelled edges) Size 19mm
Flavor Imprint Code 400;SL
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0078-0438-15 30TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021588 05/15/2001
Labeler -Novartis Pharmaceuticals Corporation(002147023)
