FDA.reportPublic FDA data

Application 077107

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5275Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5275Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5275Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5276Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5276Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5276Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5277Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5277Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5277Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0143-3367FlurazepamFlurazepam HydrochlorideWest-ward Pharmaceutical CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31197ORIG2007-02-12