FDA.reportPublic FDA data

Application 209276

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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
13107-380Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-380Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-381Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-381Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-382Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-382Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent