FDA.reportPublic FDA data

Application 209211

Type
ANDA
Sponsor
CEDIPROF INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55466-122Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-122Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-122Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-123Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-123Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
55466-123Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideNeolpharma, Inc.ANDACurrent
68462-817Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideGlenmark Pharmaceuticals, Inc.ANDACurrent
68462-818Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideGlenmark Pharmaceuticals, Inc.ANDACurrent