FDA.reportPublic FDA data

Application 076869

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

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
10544-521Metformin HydrochlorideMetformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
43063-372Metformin HydrochlorideMetformin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
51655-562Metformin hydrochlorideMetformin hydrochloride ERNorthwind PharmaceuticalsANDACurrent
62037-577Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-577Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-577Metformin HydrochlorideMetformin HydrochlorideActavis Pharma, Inc.ANDACurrent
71335-1162Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent