FDA.reportPublic FDA data

Application 078908

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL5MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGNoNo
004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5550Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5551Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5552Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5553Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31398ORIG2013-12-05