FDA.reportPublic FDA data

Application 210139

Type
ANDA
Sponsor
NOVELGENIX THERAPS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-1175Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1175Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1176Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1176Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1176Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
71930-024Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent
71930-024Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent
71930-024Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent
71930-025Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent
71930-025Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent
71930-025Methylphenidate HydrochlorideMethylphenidate HydrochlorideEywa Pharma IncANDACurrent