FDA.reportPublic FDA data

Application 204534

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-860Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-860Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-860Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-861Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-861Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-861Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-862Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-862Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-862Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent