FDA.reportPublic FDA data

Application 205879

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-940INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-941INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-942INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-943INVOKAMET XRcanagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80654SUPPL 2024-12-19
80635SUPPL 2024-12-19
80634SUPPL 2024-12-19
79483SUPPL 2024-08-26
79474SUPPL 2024-08-26
77272SUPPL 2024-01-23
77263SUPPL 2024-01-22
74708SUPPL 2023-07-07
74701SUPPL 2023-07-06
72349SUPPL2022-10-17
72347SUPPL2022-10-17
72333SUPPL2022-10-14
64320SUPPL2020-08-19
64319SUPPL2020-08-19
64307SUPPL2020-08-19
61711SUPPL2020-01-28
61710SUPPL2020-01-28
61704SUPPL2020-01-28
61694SUPPL2020-01-27
61650SUPPL2020-01-27
56212SUPPL2018-10-31
56206SUPPL2018-10-31
56199SUPPL2018-10-30
56174SUPPL2018-10-30
50958SUPPL2018-01-03
50957SUPPL2018-01-03
50516ORIG2017-11-28
49483SUPPL2017-08-21
49359SUPPL2017-08-14
49118SUPPL2017-07-28
49060SUPPL2017-07-25
45410ORIG2016-09-29
45409ORIG2016-09-29