FDA.reportPublic FDA data

Application 074028

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDESYRUP;ORAL50MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-606amantadine hydrochlorideamantadine hydrochlorideMikart, Inc.ANDACurrent
46672-606amantadine hydrochlorideamantadine hydrochlorideMikart, LLCANDACurrent
62135-010Amantadine HydrochlorideAmantadine HydrochlorideChartwell RX, LLCANDACurrent