FDA.reportPublic FDA data

Application 078083

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;250MGNoNo
002GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
003GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3131Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3132Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3132Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3133Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3133Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
70518-0116Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideREMEDYREPACK INC.ANDACurrent