FDA.reportPublic FDA data

Application 077060

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-027METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-027METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-027METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECadila Healthcare LimitedANDACurrent
68382-027METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
72578-035Metformin HydrochlorideMetformin HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-035Metformin HydrochlorideMetformin HydrochlorideViona Pharmaceuticals IncANDACurrent