FDA.reportPublic FDA data

Application 091695

Type
ANDA
Sponsor
LANNETT CO INC

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
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-310Methylphenidate HydrochlorideMethylphenidate HydrochlorideKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-311Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-312Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
62175-313Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent