Application 207414

Type
ANDA
Sponsor
LANNETT CO INC

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
0527-1914Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent
0527-1915Methylphenidate HydrochlorideMethylphenidate HydrochlorideLannett Company, Inc.ANDACurrent