;
Inactive Ingredients
Ingredient Name Strength
mannitol
croscarmellose sodium
povidone k25
magnesium stearate
gelatin
titanium dioxide
ferric oxide red
shellac
propylene glycol
sodium hydroxide
povidone
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Pfizer;STN;12;5;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0069-0550-38 28CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021938 01/26/2006
SUTENT
sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-0770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sunitinib malate(Sunitinib) Sunitinib 25mg
Inactive Ingredients
Ingredient Name Strength
mannitol
croscarmellose sodium
povidone k25
magnesium stearate
gelatin
titanium dioxide
ferric oxide red
ferric oxide yellow
ferrosoferric oxide
shellac
propylene glycol
sodium hydroxide
povidone
Product Characteristics
Color ORANGE,BROWN (caramel) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Pfizer;STN;25;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0069-0770-38 28CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021938 01/26/2006
SUTENT
sunitinib malate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-0980
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sunitinib malate(Sunitinib) Sunitinib 50mg
Inactive Ingredients
Ingredient Name Strength
mannitol
croscarmellose sodium
povidone k25
magnesium stearate
gelatin
titanium dioxide
ferric oxide red
ferric oxide yellow
ferrosoferric oxide
shellac
propylene glycol
sodium hydroxide
povidone
Product Characteristics
Color BROWN (caramel) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Pfizer;STN;50;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0069-0980-38 28CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021938 01/26/2006
Labeler -Pfizer Laboratories Div Pfizer Inc(134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Cork Limited 988786778 API MANUFACTURE
Establishment
Name Address ID/FEI Oper
