FDA.reportPublic FDA data

Application 091159

Type
ANDA
Sponsor
MOUNTAIN

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
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1800METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1801METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEImpax GenericsANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1802METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
64720-238METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECorePharma, LLCANDACurrent
64720-239METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECorePharma, LLCANDACurrent