LM COATED in 1 BOTTLE None
2 NDC:50458-140-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:50458-140-50 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:50458-140-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50458-140-10)
5 NDC:50458-140-01 5 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204042 03/29/2013
INVOKANA canagliflozin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
canagliflozin (canagliflozin anhydrous) canagliflozin anhydrous 300 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (TYPE H)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code CFZ;300
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:50458-141-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50458-141-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:50458-141-50 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:50458-141-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50458-141-10)
5 NDC:50458-141-01 5 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204042 03/29/2013
Labeler -- Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Janssen-Ortho LLC 805887986 MANUFACTURE (50458-140) (50458-141)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica NV 374747970 API MANUFACTURE (50458-140) (50458-141)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceuticals, Inc. 063137772 ANALYSIS (50458-140) (50458-141)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 PACK (50458-140) (50458-141)
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