FDA.reportPublic FDA data

Application 206748

Type
ANDA
Sponsor
ZYDUS PHARMS

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
55700-469glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
65841-824glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-824glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
65841-824glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
65841-825glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-825glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
65841-825glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
65841-826glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Lifesciences LimitedANDACurrent
65841-826glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
65841-826glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideCadila Healthcare LimitedANDACurrent
68382-653glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-653glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-653glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-653glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-654glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-654glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-654glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-654glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-655glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-655glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-655glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-655glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-6915glyburide and metformin hydrochlorideglyburide and metformin hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6915glyburide and metformin hydrochlorideglyburide and metformin hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6915glyburide and metformin hydrochlorideglyburide and metformin hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-0114glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0114glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0114glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0127glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideBryant Ranch PrepackANDACurrent
71335-0127glyburide and metformin hydrochlorideglyburide and metformin hydrochlorideBryant Ranch PrepackANDACurrent