canagliflozin Oral Tablet

Brand(s)
Invokana
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2015-09-16)
Oldest Current Product
2013-03-29
License(s)
NDA
RxNORM
ORAL TABLET\CANAGLIFLOZIN
FDAOB
ORAL\TABLET\CANAGLIFLOZIN
SPL Active
ORAL\TABLET, FILM COATED\CANAGLIFLOZIN
SPL Moiety
ORAL\TABLET, FILM COATED\CANAGLIFLOZIN ANHYDROUS

product(s) by strength(s)

canagliflozin 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580140InvokanaNDAJanssen Pharmaceuticals, Inc.2013-03-29CANAGLIFLOZINORALTABLET, FILM COATEDNDA204042b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

canagliflozin 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580141InvokanaNDAJanssen Pharmaceuticals, Inc.2013-03-29CANAGLIFLOZINORALTABLET, FILM COATEDNDA204042b9057d3b-b104-4f09-8a61-c61ef9d4a3f3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204042INVOKANAJANSSEN PHARMACEUTICALS INC2013-03-29p7943582, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p8222219, TREATMENT OF TYPE 2 DIABETES MELLITUS
p7943788, SUBSTANCE
p8513202, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
NEW CHEMICAL ENTITY [2018-03-29]NDA204042_001, NDA204042_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204042_001RXCANAGLIFLOZIN (100MG)ORALTABLETFalse2013-03-29INVOKANA
2NDA204042_002RXCANAGLIFLOZIN (300MG)ORALTABLETTrue2013-03-29INVOKANA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7943582 (view patent)2029-02-26NDA204042, NDA204353canagliflozin / Metformin Oral Tablet
2p7943788 (view patent)2027-07-14NDA204042, NDA204353canagliflozin / Metformin Oral Tablet
3p8222219 (view patent)2024-07-30NDA204042, NDA204353canagliflozin / Metformin Oral Tablet
4p8513202 (view patent)2027-12-03NDA204042, NDA204353canagliflozin / Metformin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b9057d3b-b104-4f09-8a61-c61ef9d4a3f3 (view SPL)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: 2013prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-168504580140, 504580141

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII