FDA.reportPublic FDA data

Application 077078

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-039METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-039METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-039METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECadila Healthcare LimitedANDACurrent
68382-039METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7803Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7803Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7803Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-2920Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2920Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
72578-036Metformin HydrochlorideMetformin HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-036Metformin HydrochlorideMetformin HydrochlorideViona Pharmaceuticals IncANDACurrent