FDA.reportPublic FDA data

Application 075973

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7185Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7185Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7186Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7186Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7187Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-7187Metformin Hydrochloridemetformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
51079-172Metformin Hydrochloridemetformin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-172Metformin Hydrochloridemetformin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-174Metformin Hydrochloridemetformin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-174Metformin Hydrochloridemetformin hydrochlorideMylan Institutional Inc.ANDACurrent
55154-6296Metformin Hydrochloridemetformin hydrochlorideCardinal HealthANDACurrent
55154-6296Metformin Hydrochloridemetformin hydrochlorideCardinal HealthANDACurrent
55154-6296Metformin Hydrochloridemetformin hydrochlorideCardinal HealthANDACurrent