FDA.reportPublic FDA data

Application 076716

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL1.25MG;250MGNoNo
002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1648Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0115-1649Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0115-1650Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideImpax GenericsANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideActavis Pharma, Inc.ANDACurrent
43063-397Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
67544-511Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
68788-9128Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent