FDA.reportPublic FDA data

Application 204353

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL50MG;500MGYesNo
002INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL50MG;1GMYesNo
003INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL150MG;500MGYesNo
004INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL150MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-540INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-541INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-542INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-543INVOKAMETcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
63629-8260INVOKAMETcanagliflozin and metformin hydrochlorideBryant Ranch PrepackNDACurrent
63629-8260INVOKAMETcanagliflozin and metformin hydrochlorideBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80652SUPPL 2024-12-19
80633SUPPL 2024-12-19
80632SUPPL 2024-12-19
79482SUPPL 2024-08-26
79472SUPPL 2024-08-26
77271SUPPL 2024-01-23
77261SUPPL 2024-01-22
74707SUPPL 2023-07-07
74699SUPPL 2023-07-06
72351SUPPL2022-10-17
72345SUPPL2022-10-17
72332SUPPL2022-10-14
64318SUPPL2020-08-19
64317SUPPL2020-08-19
64306SUPPL2020-08-19
61709SUPPL2020-01-28
61708SUPPL2020-01-28
61701SUPPL2020-01-28
61693SUPPL2020-01-27
61649SUPPL2020-01-27
56211SUPPL2018-10-31
56205SUPPL2018-10-31
56197SUPPL2018-10-30
56173SUPPL2018-10-30
49482SUPPL2017-08-21
49357SUPPL2017-08-14
49117SUPPL2017-07-28
49062SUPPL2017-07-25
47086SUPPL2017-02-01
47083SUPPL2017-02-01
45092SUPPL2016-08-22
45050SUPPL2016-08-17
32544SUPPL2016-05-24
10328SUPPL2016-05-24
40378SUPPL2016-05-23
40376SUPPL2016-05-23
19549SUPPL2016-03-30
10329SUPPL2016-03-30
40377SUPPL2015-12-08
10330SUPPL2015-12-08
32543SUPPL2015-09-14
19548SUPPL2015-09-11
40375SUPPL2015-03-20
10327SUPPL2015-03-04
44899ORIG2014-09-03
22952ORIG2014-09-03
19547ORIG2014-08-12
10326ORIG2014-08-11