FDA.reportPublic FDA data

Application 207901

Type
ANDA
Sponsor
TRIS PHARMA 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
27808-091Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-091Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-091Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-092Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-092Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-092Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-093Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-093Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
27808-093Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideTris Pharma IncANDACurrent
63629-2305Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2305Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2305Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2306Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2306Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2306Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2307Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2307Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-2307Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent