FDA.report

Application 074388

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDEGLYBURIDETABLET;ORAL1.25MGNoNo
002GLYBURIDEGLYBURIDETABLET;ORAL2.5MGNoNo
003GLYBURIDEGLYBURIDETABLET;ORAL5MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8342GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8342GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8342GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8343GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8343GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8343GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8344GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8344GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8344GlyburideGlyburideTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-1556GlyburideGlyburideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4509GlyburideGlyburideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-316GlyburideGlyburideAvKARE, Inc.ANDACurrent
42291-316GlyburideGlyburideAvKAREANDACurrent
42291-317GlyburideGlyburideAvKARE, Inc.ANDACurrent
42291-317GlyburideGlyburideAvKAREANDACurrent
49999-113GlyburideGlyburideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0494GlyburideGlyburideA-S Medication SolutionsANDACurrent
50090-3429GlyburideGlyburideA-S Medication SolutionsANDACurrent
50090-3429GlyburideGlyburideA-S Medication SolutionsANDACurrent
50090-3429GlyburideGlyburideA-S Medication SolutionsANDACurrent
50436-6409GlyburideGlyburideUnit Dose ServicesANDACurrent
51079-872GlyburideGlyburideMylan Institutional Inc.ANDACurrent
51079-872GlyburideGlyburideMylan Institutional Inc.ANDACurrent
51079-873GlyburideGlyburideMylan Institutional Inc.ANDACurrent
51079-873GlyburideGlyburideMylan Institutional Inc.ANDACurrent
63187-848GlyburideGlyburideProficient Rx LPANDACurrent
63187-848GlyburideGlyburideProficient Rx LPANDACurrent
63629-1393GlyburideGlyburideBryant Ranch PrepackANDACurrent
63629-1393GlyburideGlyburideBryant Ranch PrepackANDACurrent
63629-2907GlyburideGlyburideBryant Ranch PrepackANDACurrent
63629-2907GlyburideGlyburideBryant Ranch PrepackANDACurrent
63739-119GlyburideGlyburideMcKesson Corporation dba SKY PackagingANDACurrent
63739-119GlyburideGlyburideMcKesson CorporationANDACurrent
63739-119GlyburideGlyburideMcKesson Corporation dba SKY PackagingANDACurrent
66116-360GlyburideGlyburideMedVantx, Inc.ANDACurrent
68071-2189GlyburideGlyburideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6885GlyburideGlyburidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6885GlyburideGlyburidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6885GlyburideGlyburidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0019GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70934-715GlyburideGlyburideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent