MedPath
FDA Product

INVOKANA

Product approved by U.S. Food and Drug Administration (US)

Basic Information

INVOKANA

55154-1426

Regulatory Information

55154-1426

NDA204042

C73594

December 13, 2018

USA

These highlights do not include all the information needed to use INVOKANA safely and effectively. See full prescribing information for INVOKANA. INVOKANA (canagliflozin) tablets, for oral use Initial U.S. Approval: 2013

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

118546603

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

canagliflozin

Quantity: 300 mg in 1 1

Code: 0SAC974Z85

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Hydroxypropyl Cellulose (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

Active Moieties

canagliflozin anhydrous

Code: 6S49DGR869

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