canagliflozin / Metformin Oral Tablet

Brand(s)
Invokamet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2015-09-16)
Oldest Current Product
2014-08-08
License(s)
NDA
RxNORM
ORAL TABLET\CANAGLIFLOZIN:METFORMIN
FDAOB
ORAL\TABLET\CANAGLIFLOZIN: METFORMIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\CANAGLIFLOZIN: METFORMIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\CANAGLIFLOZIN ANHYDROUS: METFORMIN

product(s) by strength(s)

canagliflozin 150 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580543InvokametNDAJanssen Pharmaceuticals, Inc.2014-08-08CANAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA2043536868666b-c25e-40d1-9d1f-306bbe9390c1

canagliflozin 150 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580542InvokametNDAJanssen Pharmaceuticals, Inc.2014-08-08CANAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA2043536868666b-c25e-40d1-9d1f-306bbe9390c1

canagliflozin 50 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580541InvokametNDAJanssen Pharmaceuticals, Inc.2014-08-08CANAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA2043536868666b-c25e-40d1-9d1f-306bbe9390c1

canagliflozin 50 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580540InvokametNDAJanssen Pharmaceuticals, Inc.2014-08-08CANAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA2043536868666b-c25e-40d1-9d1f-306bbe9390c1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204353INVOKAMETJANSSEN PHARMACEUTICALS INC2014-08-08p7943582, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p8222219, TREATMENT OF TYPE 2 DIABETES MELLITUS
p8785403, SUBSTANCE
p7943788, SUBSTANCE
p8513202, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
NEW COMBINATION [2017-08-08]
NEW CHEMICAL ENTITY [2018-03-29]
NDA204353_001, NDA204353_002, NDA204353_003, NDA204353_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204353_001RXMETFORMIN HYDROCHLORIDE (500MG), CANAGLIFLOZIN (50MG)ORALTABLETFalse2014-08-08INVOKAMET
2NDA204353_002RXCANAGLIFLOZIN (50MG), METFORMIN HYDROCHLORIDE (1GM)ORALTABLETFalse2014-08-08INVOKAMET
3NDA204353_003RXMETFORMIN HYDROCHLORIDE (500MG), CANAGLIFLOZIN (150MG)ORALTABLETFalse2014-08-08INVOKAMET
4NDA204353_004RXMETFORMIN HYDROCHLORIDE (1GM), CANAGLIFLOZIN (150MG)ORALTABLETTrue2014-08-08INVOKAMET

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7943582 (view patent)2029-02-26NDA204353, NDA204042canagliflozin Oral Tablet
2p7943788 (view patent)2027-07-14NDA204353, NDA204042canagliflozin Oral Tablet
3p8222219 (view patent)2024-07-30NDA204353, NDA204042canagliflozin Oral Tablet
4p8513202 (view patent)2027-12-03NDA204353, NDA204042canagliflozin Oral Tablet
5p8785403 (view patent)2024-07-30NDA204353

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16868666b-c25e-40d1-9d1f-306bbe9390c1 (view SPL)These highlights do not include all the information needed to use INVOKAMET safely and effectively. See full prescribing information for INVOKAMET. INVOKAMET (canagliflozin and metformin hydrochloride) tablets, for oral useInitial U.S. Approval 2014prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-09-164504580540, 504580541, 504580542, 504580543

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