FDA.reportPublic FDA data

Application 212697

Type
ANDA
Sponsor
PRINSTON 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
43547-486Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-486Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-486Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-486Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-486Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-487Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-487Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-487Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-487Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-487Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-488Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-488Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-488Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent
43547-488Methylphenidate hydrochlorideMethylphenidate hydrochlorideSolco Healthcare US,LLCANDACurrent