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FERRIC OXIDE RED
HYPROMELLOSE 2910 (15000 MPA.S)
Product Characteristics
Color RED Score no score
Shape OVAL Size 9mm
Flavor Imprint Code Pfizer;1;XNB
Contains
Packaging
Item Code Package Description
1 NDC:0069-0145-01 180 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202324 01/27/2012
Inlyta
axitinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-0151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AXITINIB (AXITINIB) AXITINIB 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
HYPROMELLOSE 2910 (15000 MPA.S)
Product Characteristics
Color RED Score no score
Shape TRIANGLE Size 8mm
Flavor Imprint Code Pfizer;5;XNB
Contains
Packaging
Item Code Package Description
1 NDC:0069-0151-11 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202324 01/27/2012
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 989811526 API MANUFACTURE(0069-0151, 0069-0145)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 ANALYSIS(0069-0151, 0069-0145), PACK(0069-0151, 0069-0145)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Deutschland GmbH (Betriebsstätte Freiburg) 341970073 MANUFACTURE(0069-0151, 0069-0145)
Revised: 01/2012
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