FDA.reportPublic FDA data

Application 203414

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KAZANOALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE;500MGYesNo
002KAZANOALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-169alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals LtdNDACurrent
45802-169alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePerrigo New York IncNDACurrent
45802-169alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals LtdNDACurrent
45802-169alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePerrigo New York IncNDACurrent
45802-211alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePerrigo New York IncNDACurrent
45802-211alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals LtdNDACurrent
45802-211alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePerrigo New York IncNDACurrent
45802-211alogliptin and metformin hydrochloridealogliptin and metformin hydrochloridePadagis Israel Pharmaceuticals LtdNDACurrent
50090-5993alogliptin and metformin hydrochloridealogliptin and metformin hydrochlorideA-S Medication SolutionsNDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-335KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-337KAZANOalogliptin and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74946SUPPL 2023-07-31
74927SUPPL 2023-07-31
74926SUPPL 2023-07-31
70518SUPPL2022-03-15
70517SUPPL2022-03-15
70509SUPPL2022-03-14
59257SUPPL2019-07-05
59212SUPPL2019-07-02
56368SUPPL2018-11-08
47253SUPPL2017-02-16
46168SUPPL2016-12-15
46167SUPPL2016-12-15
46148SUPPL2016-12-14
46147SUPPL2016-12-14
40295SUPPL2016-04-07
10210SUPPL2016-04-07
19464SUPPL2015-09-21
10211SUPPL2015-09-01
43430ORIG2014-04-18
24434ORIG2014-04-18
43966ORIG2013-02-05
40294ORIG2013-01-30
32420ORIG2013-01-30