FDA.reportPublic FDA data

Application 022426

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 25MG BASE;EQ 15MG BASEYesNo
002OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 25MG BASE;EQ 30MG BASEYesNo
003OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 25MG BASE;EQ 45MG BASEYesYes
004OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE;EQ 15MG BASEYesNo
005OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE;EQ 30MG BASEYesNo
006OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE;EQ 45MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-238Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-238Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-238Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-238Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-238Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-260Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-260Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-260Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-260Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-260Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-304Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-304Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-304Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-304Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-304Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-351Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-351Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-351Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-351Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-351Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-402Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-402Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-402Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-402Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-402Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-499Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-499Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-499Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-499Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-499Alogliptin and PioglitazoneAlogliptin Benzoate and Pioglitazone hydrochloridePerrigo New York IncNDA AUTHORIZED GENERICCurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-121OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-123OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-124OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-251OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-253OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-254OSENIalogliptin and pioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78955SUPPL 2024-07-02
78938SUPPL 2024-07-01
78937SUPPL 2024-07-01
70516SUPPL2022-03-15
70515SUPPL2022-03-15
70508SUPPL2022-03-14
59256SUPPL2019-07-05
59255SUPPL2019-07-05
59211SUPPL2019-07-02
50920SUPPL2017-12-27
50856SUPPL2017-12-26
46562SUPPL2016-12-27
46197SUPPL2016-12-19
46145SUPPL2016-12-14
46142SUPPL2016-12-13
38700SUPPL2016-04-07
7379SUPPL2016-04-07
17578SUPPL2015-09-21
29721SUPPL2015-09-01
22018ORIG2014-04-17
44503ORIG2013-02-12
29720ORIG2013-02-12
17577ORIG2013-02-12