FDA.reportPublic FDA data

Application 078458

Type
ANDA
Sponsor
MAYNE PHARMA

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;ORAL60MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
51862-263Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-263Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-264Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-264Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-265Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-265Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-267Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-610Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-610Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-610Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-610Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-611Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-611Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-611Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-611Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-612Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-612Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-612Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-612Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-614Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18482SUPPL2016-06-27
9155SUPPL2016-06-24
43142ORIG2012-03-02