FDA.reportPublic FDA data

Application 206749

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDEGLYBURIDETABLET;ORAL1.25mgNoNo
002GLYBURIDEGLYBURIDETABLET;ORAL2.5mgNoNo
003GLYBURIDEGLYBURIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3012glyburideglyburideA-S Medication SolutionsANDACurrent
65841-832glyburideglyburideZydus Lifesciences LimitedANDACurrent
65841-832glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-832glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-833glyburideglyburideZydus Lifesciences LimitedANDACurrent
65841-833glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-833glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-834glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-834glyburideglyburideCadila Healthcare LimitedANDACurrent
65841-834glyburideglyburideZydus Lifesciences LimitedANDACurrent
68382-656glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-656glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-656glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-657glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-657glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-657glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-658glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-658glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-658glyburideglyburideZydus Pharmaceuticals (USA) Inc.ANDACurrent