FDA.reportPublic FDA data

Application 202892

Type
ANDA
Sponsor
OXFORD PHARMS

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
0603-4576Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4576Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4577Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4577Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4578Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent
0603-4578Methylphenidate Hydrochloridemethylphenidate hydrochloridePar PharmaceuticalANDACurrent