FDA.reportPublic FDA data

Application 076772

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL18MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL27MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL36MGNoNo
004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL54MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62037-725Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-725Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-725Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-726Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-726Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-726Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-734Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-734Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-734Methylphenidate HydrochlorideMethylphenidate HydrochlorideActavis Pharma, Inc.ANDACurrent