FDA.reportPublic FDA data

Application 200886

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-262Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-262Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-609Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-609Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-609Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-609Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent
51862-609Methylphenidate Hydrochloride (LA)Methylphenidate HydrochlorideMayne PharmaANDACurrent