FDA.reportPublic FDA data

Application 017532

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIABETAGLYBURIDETABLET;ORAL1.25MGYesNo
002DIABETAGLYBURIDETABLET;ORAL2.5MGYesNo
003DIABETAGLYBURIDETABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-9364GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9364GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9364GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9433GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9433GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9433GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9477GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9477GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-9477GlyburideglyburideTEVA Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-433GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43353-656GlyburideglyburideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-656GlyburideglyburideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-659GlyburideglyburideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-659GlyburideglyburideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-895GlyburideglyburideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, InNDA AUTHORIZED Current
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-606GlyburideglyburidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3097GlyburideglyburideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-2695GlyburideglyburideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2695GlyburideglyburideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2695GlyburideglyburideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70934-409GlyburideglyburideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70934-409GlyburideglyburideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46879SUPPL2017-01-18
46803SUPPL2017-01-11
11018SUPPL2013-10-21
622SUPPL2013-10-16
11017SUPPL2009-07-23
621SUPPL2009-07-15
33294SUPPL2009-03-17
11016SUPPL2009-03-17
13834SUPPL2009-03-10
620SUPPL2009-03-10