FDA.reportPublic FDA data

Application 201231

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

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
57664-376Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-376Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-376Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-376Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-378Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-378Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-378Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-378Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-379Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-379Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-379Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-379Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63629-1096Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-1096Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-1097Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-1097Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-1098Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent
63629-1098Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9867ORIG2015-09-28