FDA.reportPublic FDA data

Application 208737

Type
ANDA
Sponsor
CEDIPROF INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55466-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-101Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-102Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-103Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-103Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-103Methylphenidate HydrochlorideMethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent