FDA.reportPublic FDA data

Application 022271

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NESINAALOGLIPTIN BENZOATETABLET;ORALEQ 6.25MG BASEYesNo
002NESINAALOGLIPTIN BENZOATETABLET;ORALEQ 12.5MG BASEYesNo
003NESINAALOGLIPTIN BENZOATETABLET;ORALEQ 25MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-087AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-087AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-087AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-087AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-103AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-103AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-103AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-103AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-150AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
45802-150AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-150AlogliptinAlogliptinPerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-150AlogliptinAlogliptinPadagis Israel Pharmaceuticals LtdNDA AUTHORIZED GENERICCurrent
50090-5574AlogliptinAlogliptinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5574AlogliptinAlogliptinA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-125NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-250NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-625NesinaalogliptinTakeda Pharmaceuticals America, Inc.NDACurrent
71610-300AlogliptinAlogliptinAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-661AlogliptinAlogliptinAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-661AlogliptinAlogliptinAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74945SUPPL 2023-07-31
74929SUPPL 2023-07-31
74928SUPPL 2023-07-31
70531SUPPL2022-03-16
70514SUPPL2022-03-15
70507SUPPL2022-03-14
59254SUPPL2019-07-05
59253SUPPL2019-07-05
59210SUPPL2019-07-02
46169SUPPL2016-12-15
46146SUPPL2016-12-14
17175SUPPL2016-06-01
7144SUPPL2016-05-31
38475SUPPL2016-04-07
7142SUPPL2016-04-07
38476SUPPL2015-09-21
7143SUPPL2015-09-01
44722ORIG2013-03-25
21974ORIG2013-03-25
43846ORIG2013-02-05
38474ORIG2013-01-30
7141ORIG2013-01-30