sium stearate
titanium dioxide
triacetin
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
Multilevel Packaging
1
NDC:0069-0145-01
180 TABLET, FILM COATED ( TABLET) in 1 BOTTLE
None
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
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
Multilevel Packaging
1
NDC:0069-0151-11
60 TABLET, FILM COATED ( TABLET) in 1 BOTTLE
None
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
Addess
ID/FEI
Operations
Pfizer Ireland Pharmaceuticals
989811526
API MANUFACTURE
Establishment
Name
Address
ID/FEI
Operations
Pfizer Manufacturing Deutschland GmBH
341970073
MANUFACTURE
Establishment
Name
Address
ID/FEI
Operations
Pfizer Pharmaceuticals LLC
829084552
PACK, ANALYSI
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