FDA.reportPublic FDA data

Application 079031

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo
004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5346Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5346Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5346Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5346Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5347Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5347Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5347Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5347Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5348Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5348Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5348Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5348Methylphenidate HydrochlorideMethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent